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Legislative Progress
Introduced
January 29, 2015
Latest Action
January 29, 2015
Primary Sponsor
Elizabeth WarrenDemocratic(MA)
Momentum (last 30 days)
0
score
0 actions · 0 new cosponsors · 0 votes
Speed vs cohort
0pct
0d open
vs 3,548 other S bills in the 114th — cohort avg 43d
Medical Innovation Act of 2015 This bill amends the Public Health Service Act to require certain drug manufacturers to make payments to fund research supported by the Food and Drug Administration (FDA) and the National Institutes of Health (NIH). A drug manufacturer with over $1 billion in net income in a fiscal year that has entered into a settlement agreement in the previous five years with a federal agency regarding specified violations must pay 1% of its net income to the Department of Health and Human Services (HHS) for each of its covered blockbuster drugs. A covered blockbuster drug is a drug that has at least $1 billion in net sales in a year and was developed, in whole or in part, through federal investments in medical research, including a drug for which a patent contains information that relates to, or is based upon, federally-funded research. Each fiscal year, HHS must publish a list of manufacturers that make payments, each manufacturer's covered blockbuster drugs, and payment amounts. Payments are divided between the FDA and the NIH in proportion to the discretionary funding of those agencies, excluding FDA user fees. Payments are not disbursed if appropriations for the FDA or the NIH are lower than in the prior fiscal year. The FDA's priority use for payments must include advancing regulatory science for medical products. The NIH's priority use for payments must include supporting: (1) research that fosters radical innovation, (2) research that advances fundamental knowledge, (3) research related to diseases that disproportionately account for federal health care spending, and (4) early career scientists. A covered blockbuster drug for which a manufacturer has not made a required payment is considered misbranded and cannot be sold until payment is made.
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Filing registrants (23)
Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (Sponsor introductory remarks on measure: CR S657-658)
Introduced in Senate
Bills with similar content found using semantic analysis.
Sources: Congress.gov
2016 · fourth_quarter · Health Issues
Implementation of Patient Protection & Affordable Health Care Act (P.L. 111-148) and Implementation of Health Care and Education Reconciliation Act (P.L. 111-152) 340B issues and legislative reform proposals Issues related to importation of prescription drugs, including those contained in S. 122, Safe and Affordable Drugs from Canada Act of 2015 Health technology assessment of orphan drugs Sequestration of FDA user fees H.R. 1376, Patient Choice Act of 2015 H.R. 790, Compassionate Freedom of Choice Act of 2015 H.R. 1600, Patients' Access to Treatments Act of 2015 21st Century Cures/Innovation initiatives including H.R. 6, 21st Century Cures Act and the Innovation for Healthier Americans Initiative, including the following: S. 2055, The Medical Countermeasures Innovation Act of 2015; S. 2512, Adding Zika Virus to the FDA Priority Review Voucher Program Act; S. 2030, The Advancing Targeted Therapies for Rare Diseases Act of 2015; S. 849, Advancing Research for Neurological Diseases Act of 2015; S. 2700, FDA and NIH Workforces Authorities Modernization Act H.R. 909, Andrea Sloan CURE Act S. 1421 and H.R.971, Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 Implementation of the FDA Safety and Innovation Act (FDASIA) (Pub. L. 112-144) Regulation of innovative biological products for neurodegenerative diseases Issues and policies related to implementation of Orphan Drug Act and orphan drug development S. 320, Medical Innovation Act H.R. 744, Medical Innovation Act S. 2615, Increasing Competition in Pharmaceuticals Act H.R. 1130, Chronic Kidney Disease Improvement in Research and Treatment Act of 2015 S. 598, Chronic Kidney Disease Improvement in Research and Treatment Act of 2015 H.R. 1078, Food and Drug Administration Safety Over Sequestration Act of 2015 H.R. 1531 and S.1878, Advancing Hope Act of 2015 Implementation of newborn screening programs Issues and policies related to biosimilars exclusivity period Issues and policies related to biosimilars FDA guidance Issues and policies related to FDA oversight and management Issues and policies related to expanded access programs Issues and policies related to patient involvement with FDA decision making S. 289 and H.R. 2104, American Cures Act Legislation pertaining to FDA priority review vouchers, generally Legislation pertaining to the applicability of the ACA tax carve out for non-orphan drug designated drugs, generally, including H.R. 3678, Preserving Access to Orphan Drugs Act of 2015 H.R. 3618 and S. 1906, Orphan Drug Fairness Act Issues related to the value of prescription medicines, generally, and including S. 2023, Prescription Drug Affordability Act of 2015 Drug shortage issues Issues related to health care transparency S. 2055, Medical Countermeasure Innovation Act of 2016 H.R. 3299, Strengthening Public Health Emergency Response Act S. 2700, FDA and NIH Workforce Authorities Modernization Act S. 2713, Advancing Precision Medicine Act of 2016 S. 2745, Advancing NIH Strategic Planning and Representation in Medical Research Act S. 2742, Promoting Biomedical Research and Public Health for Patients Act S. 3239, H.R. 5858, The RACE for Children Act S. 2689, The REGROW Act S. 1878, Advancing Hope Act of 2016
Client expense: $260,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Health Issues
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 289: American Cures Act - Provisions related to National Institutes of Health (NIH) funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: Combination Product Regulatory Fairness Act of 2016 - Provisions related to improvements in the regulation of combination drug-device products S. 1878: Advancing Hope Act of 2016 - Provisions related to pediatric cancer and other pediatric diseases S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act - Provisions related to priority review vouchers S. 2615: Increasing Competition in Pharmaceuticals Act - Provisions related to FDA review of generic drugs and study on risk evaluation and mitigation strategies (REMS) program S. 2689: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments S. 2700: FDA and NIH Workforce Modernization Act - Provisions related to FDA and NIH S. 2912: Trickett Wendler Right to Try Act of 2016 - A bill to authorize the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law, and for other purposes - Provisions related to use of unapproved medical products by patients with a terminal illness S. 3056: CREATES Act of 2016 - Provisions related to access to samples of prescription drugs S. 3239: RACE for Children Act - Provisions related to pediatric studies S. 3335: Fair Accountability and Innovative Research (FAIR) Drug Pricing Act - Provisions relating to transparency H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 1270 - Restoring Access to Medication and Improving Health Savings Act of 2016 - FSA and HSA use for over the counter medication H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 or FAST Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing H.R. 3012: Right to Try Act of 2015 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 3250 - DXM Abuse Prevention Act of 2015 - age requirement for purchase of OTC medication including dextromethorphan Monograph reform H.R. 4762: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments H.R. 4784: Lower Drug Costs Through Competition Act - Provisions related to generic drugs and priority review vouchers; REMS study; and tropical disease product applications H.R. 5122: A bill to prohibit further action on the proposed rule regarding testing of Medicare Part B prescription drug models H.R. 5858: The RACE for Children Act - Provisions related to pediatric studies H.R. 6043: Fair Accountability and Innovative Research (FAIR) Drug Pricing Act of 2016 - Provisions related to transparency H.R. 6174: Closing Loopholes for Orphan Drugs Act - Provisions relating to 340B discounts on orphan drugs Kids Innovative Drugs Act (draft) - Incentives for the development of pediatric oncology drugs The Regenerative Medicine Regulatory Improvement Act (discussion draft) - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) - Incentives for the development of pediatric drugs Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Proposed HRSA 340B program mega-guidance - Provisions related to 340B program Implementation and other issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges 340B Drug Discount Program policy issues General FDA advocacy including sharing of truthful and non-misleading information about medicines with healthcare professionals Prescription Drug User Fee Act (PDUFA) reauthorization Biosimilar User Fee Act (BsUFA) reauthorization Biologics Price Competition and Innovation Act (BPCIA) implementation issues Biopharmaceutical and medical innovation policy issues Drug development ecosystem policy issues Drug cost and pricing policy issues Expedited drug approval policy issues Compassionate use policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Transparency policy issues NIH Funding policy issues Precision Medicine Initiative Biomarker policy issues Policy issues related to prescription drug abuse and secure disposal Drug compounding policy issues Prescription drug importation policy issues Cancer Moonshot Prescription drug take back policy issues Clinical trial policy issues Pediatric cancer policy issues Cancer drug vial size policy issues House Republican Health Proposal (A Better Way) Expanded access policy issues
2016 · fourth_quarter · Health Issues
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 289: American Cures Act - Provisions related to National Institutes of Health (NIH) funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 2615: Increasing Competition in Pharmaceuticals Act - Provisions related to FDA review of generic drugs and study on risk evaluation and mitigation strategies (REMS) program S. 2680: Mental Health Reform Act of 2016 - Provisions related to mental health issues S. 2689: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments S. 2700: FDA and NIH Workforce Modernization Act - Provisions related to FDA and NIH S. 2912: Trickett Wendler Right to Try Act of 2016 - A bill to authorize the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law, and for other purposes - Provisions related to use of unapproved medical products by patients with a terminal illness S. 3056: CREATES Act of 2016 - Provisions related to access to samples of prescription drugs S. 3335: Fair Accountability and Innovative Research (FAIR) Drug Pricing Act - Provisions relating to transparency H.R. 6 / H.R. 34: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2805: Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 - Provisions related to the treatment of heroin and prescription opioid abuse H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 or FAST Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing H.R. 3012: Right to Try Act of 2015 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 3381: Childhood Cancer STAR Act - Provisions related to expanded access and other issues H.R. 4762: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments H.R. 4784: Lower Drug Costs Through Competition Act - Provisions related to generic drugs and priority review vouchers; REMS study; and tropical disease product applications H.R. 5122: A bill to prohibit further action on the proposed rule regarding testing of Medicare Part B prescription drug models H.R. 5858: The RACE for Children Act - Provisions related to pediatric studies H.R. 6043: Fair Accountability and Innovative Research (FAIR) Drug Pricing Act of 2016 - Provisions related to transparency H.R. 6174: Closing Loopholes for Orphan Drugs Act - Provisions relating to 340B discounts on orphan drugs Kids Innovative Drugs Act (draft) - Incentives for the development of pediatric oncology drugs The Regenerative Medicine Regulatory Improvement Act (discussion draft) - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) - Incentives for the development of pediatric drugs Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Proposed HRSA 340B program mega-guidance - Provisions related to 340B program Implementation and other issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges 340B Drug Discount Program policy issues General FDA advocacy including sharing of truthful and non-misleading information about medicines with healthcare professionals Prescription Drug User Fee Act (PDUFA) reauthorization Biosimilar User Fee Act (BsUFA) reauthorization Biologics Price Competition and Innovation Act (BPCIA) implementation issues Biopharmaceutical and medical innovation policy issues Drug development ecosystem policy issues Drug cost and pricing policy issues Expedited drug approval policy issues Compassionate use policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Transparency policy issues NIH Funding policy issues Precision Medicine Initiative Biomarker policy issues Policy issues related to prescription drug abuse and secure disposal Drug compounding policy issues Prescription drug importation policy issues Cancer Moonshot Prescription drug take back policy issues Clinical trial policy issues Pediatric cancer policy issues Cancer drug vial size policy issues House Republican Health Proposal (A Better Way) Expanded access policy issues
2016 · fourth_quarter · Health Issues
National Diabetes Prevention Program; Better care and treatment of people with diabetes under P.L. 111-148 Patient Protection and Affordable Care Act of 2009 (ACA) and P.L. 111-152 The Health Care & Education Affordability Reconciliation Act of 2010: Issues related to diabetes generally, and specifically diabetes screening, medical education and death certificate reporting (Catalyst for Better Diabetes), AHRQ and USPSTF diabetes screening standards; H.R. 1192 and S. 586 National Diabetes Clinical Care Commission Act of 2015; P.L. 114-10, Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) for Special Diabetes Program, CHIP, and childhood obesity; H.R. 1190 and S. 141 Protecting Seniors' Access to Medicare Act of 2015 (IPAB repeal); H.R. 2651 Eliminating Disparities in Diabetes Prevention, Access, and Care Act of 2015 (EDDPAC); cost of diabetes generally; S. 320 and H.R. 744 Medical Innovation Act of 2015; S. 2023 and H.R. 3513 Prescription Drug Affordability Act of 2015; H.R. 3742, Access to Marketplace Insurance Act and general allowance for certain third party payments of cost sharing; H.R. 6, 21st Century Cures Act.
Client expense: Not reported · Firm income: $60,000
2016 · fourth_quarter · Health Issues
National Diabetes Prevention Program; Better care and treatment of people with diabetes under P.L. 111-148 Patient Protection and Affordable Care Act of 2009 (ACA) and P.L. 111-152 The Health Care & Education Affordability Reconciliation Act of 2010: Issues related to diabetes generally, and specifically diabetes screening, medical education and death certificate reporting (Catalyst for Better Diabetes), AHRQ and USPSTF diabetes screening standards; diabetes issues in Healthy People 2020 and the Office of Disease Prevention and Health Promotion (ODPHP); H.R. 1192 and S. 586 National Diabetes Clinical Care Commission Act of 2015; P.L. 114-10, Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) for Special Diabetes Program, CHIP, and childhood obesity; S. 84 and H.R. 3658 Gestational Diabetes Act of 2015; H.R. 1190 and S. 141 Protecting Seniors' Access to Medicare Act of 2015 (IPAB repeal); H.R. 2651 Eliminating Disparities in Diabetes Prevention, Access, and Care Act of 2015 (EDDPAC); cost of diabetes generally; S. 320 and H.R. 744 Medical Innovation Act of 2015; S. 2023 and H.R. 3513 Prescription Drug Affordability Act of 2015; H.R. 3742, Access to Marketplace Insurance Act and general allowance for certain third party payments of cost sharing; Congressional recognition of World Hemophilia Day and Growth Awareness Week.
Client expense: $262,000 · Firm income: Not reported
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Client expense: $492,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Trade Representative (USTR)
Client expense: $4,990,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)
Government targets: HOUSE OF REPRESENTATIVES, SENATE
Government targets: Centers For Disease Control & Prevention (CDC), 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), Health Resources & Services Administration (HRSA), Indian Health Service, Labor, Dept of (DOL), Natl Institutes of Health (NIH), SENATE, Treasury, Dept of
2016 · fourth_quarter · Medical/Disease Research/Clinical Labs
S. 320, The Medical Innovation Act. Legislation to authorize the collection of supplemental payments to increase congressional investments in medical research. H.R. 34, 21st Century Cures Act, (multiple provisions including incentives for innovation to help expedite novel treatments and cures, enhancements to FDA capacity and resources, and promotion of precision therapies, potential offsets) Senate Innovations for Healthy Americans Act (text not yet available but likely multiple provisions similar to H.R. 6 including incentives for innovation to help expedite novel treatments and cures, enhancements to FDA capacity and resources, and promotion of precision therapies, potential offsets) S. 1878, Advancing Hope Act of 2015 legislation that amends the Federal Food, Drug, and Cosmetic Act to expand the priority review voucher program for rare pediatric diseases to include treatments for sickle cell disease and pediatric cancers.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Medical/Disease Research/Clinical Labs
H.R. 34, 21st Century Cures Act, (multiple provisions including incentives for innovation to help expedite novel treatments and cures, enhancements to FDA capacity and resources, and promotion of precision therapies, potential offsets) S. 320, The Medical Innovation Act. Legislation to authorize the collection of supplemental payments to increase congressional investments in medical research. S. 1878, Advancing Hope Act of 2015 legislation that amends the Federal Food, Drug, and Cosmetic Act to expand the priority review voucher program for rare pediatric diseases to include treatments for sickle cell disease and pediatric cancers.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · third_quarter · Health Issues
Implementation of Patient Protection & Affordable Health Care Act (P.L. 111-148) and Implementation of Health Care and Education Reconciliation Act (P.L. 111-152) 340B issues and legislative reform proposals Issues related to importation of prescription drugs, including those contained in S. 122, Safe and Affordable Drugs from Canada Act of 2015 Health technology assessment of orphan drugs Sequestration of FDA user fees H.R. 1376, Patient Choice Act of 2015 H.R. 790, Compassionate Freedom of Choice Act of 2015 H.R. 1600, Patients' Access to Treatments Act of 2015 21st Century Cures/Innovation initiatives including H.R. 6, 21st Century Cures Act and the Innovation for Healthier Americans Initiative, including the following: S. 2055, The Medical Countermeasures Innovation Act of 2015; S. 2512, Adding Zika Virus to the FDA Priority Review Voucher Program Act; S. 2030, The Advancing Targeted Therapies for Rare Diseases Act of 2015; S. 849, Advancing Research for Neurological Diseases Act of 2015; S. 2700, FDA and NIH Workfroces Authorities Modernization Act H.R. 909, Andrea Sloan CURE Act S. 1421 and H.R.971, Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 Implementation of the FDA Safety and Innovation Act (FDASIA) (Pub. L. 112-144) Regulation of innovative biological products for neurodegenerative diseases Issues and policies related to implementation of Orphan Drug Act and orphan drug development S. 320, Medical Innovation Act H.R. 744, Medical Innovation Act S. 2615, Increasing Competition in Pharmaceuticals Act H.R. 1130, Chronic Kidney Disease Improvement in Research and Treatment Act of 2015 S. 598, Chronic Kidney Disease Improvement in Research and Treatment Act of 2015 H.R. 1078, Food and Drug Administration Safety Over Sequestration Act of 2015 H.R. 1531 and S.1878, Advancing Hope Act of 2015 Implementation of newborn screening programs Issues and policies related to biosimilars exclusivity period Issues and policies related to biosimilars FDA guidance Issues and policies related to FDA oversight and management Issues and policies related to expanded access programs Issues and policies related to patient involvement with FDA decision making S. 289 and H.R. 2104, American Cures Act Legislation pertaining to FDA priority review vouchers, generally Legislation pertaining to the applicability of the ACA tax carve out for non-orphan drug designated drugs, generally, including H.R. 3678, Preserving Access to Orphan Drugs Act of 2015 H.R. 3618 and S. 1906, Orphan Drug Fairness Act Issues related to the value of prescription medicines, generally, and including S. 2023, Prescription Drug Affordability Act of 2015 Drug shortage issues Issues related to health care transparency S. 2055, Medical Countermeasure Innovation Act of 2016 H.R. 3299, Strengthening Public Health Emergency Response Act S. 2700, FDA and NIH Workforce Authorities Modernization Act S. 2713, Advancing Precision Medicine Act of 2016 S. 2745, Advancing NIH Strategic Planning and Representation in Medical Research Act S. 2742, Promoting Biomedical Research and Public Health for Patients Act S. 3239, H.R. 5858, The RACE for Children Act S. 2689, The REGROW Act S. 1878, Advancing Hope Act of 2016
Client expense: $270,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2016 · third_quarter · Health Issues
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 289: American Cures Act - Provisions related to National Institutes of Health (NIH) funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 524: Comprehensive Addiction and Recovery Act of 2016 - Provisions related to opioids S. 1077: Advancing Breakthrough Devices for Patients Act of 2016 - Issues related to the biopharmaceutical industry S. 1597: Patient-Focused Impact Assessment Act of 2016 - Provisions related to patient-focused drug development S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: Combination Product Regulatory Fairness Act of 2016 - Provisions related to improvements in the regulation of combination drug-device products S. 1878: Advancing Hope Act of 2016 - Provisions related to pediatric cancer and other pediatric diseases S.2055: Medical Countermeasure Innovation Act of 2015 S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act - Provisions related to priority review vouchers S. 2615: Increasing Competition in Pharmaceuticals Act - Provisions related to FDA review of generic drugs and study on risk evaluation and mitigation strategies (REMS) program S. 2680: Mental Health Reform Act of 2016 - Provisions related to mental health issues S. 2689: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments S. 2700: FDA and NIH Workforce Modernization Act - Provisions related to FDA and NIH S. 2912: Trickett Wendler Right to Try Act of 2016 - A bill to authorize the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law, and for other purposes - Provisions related to use of unapproved medical products by patients with a terminal illness S. 3056: CREATES Act of 2016 - Provisions related to access to samples of prescription drugs S. 3239: RACE for Children Act - Provisions related to pediatric studies S. 3335: Fair Accountability and Innovative Research (FAIR) Drug Pricing Act - Provisions relating to transparency H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 1538: Compassionate Access, Research Expansion, and Respect States (CARERS) Act of 2015 - Provisions related to regulation of marijuana and impact on medical research H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2805: Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 - Provisions related to the treatment of heroin and prescription opioid abuse H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 or FAST Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing H.R. 3012: Right to Try Act of 2015 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 3250: DXM Abuse Prevention Act of 2015 H.R. 3299: The Strengthening Public Health Emergency Response Act of 2015 H.R. 3381: Childhood Cancer STAR Act - Provisions related to expanded access and other issues H.R. 4762: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments H.R. 4784: Lower Drug Costs Through Competition Act - Provisions related to generic drugs and priority review vouchers; REMS study; and tropical disease product applications H.R. 5046: Comprehensive Opioid Abuse Reduction Act of 2016 - Provisions related to opioids H.R. 5122: A bill to prohibit further action on the proposed rule regarding testing of Medicare Part B prescription drug models H.R. 5858: The RACE for Children Act - Provisions related to pediatric studies H.R. 6043: Fair Accountability and Innovative Research (FAIR) Drug Pricing Act of 2016 - Provisions related to transparency H.R. 6174: Closing Loopholes for Orphan Drugs Act - Provisions relating to 340B discounts on orphan drugs Other: - Kids Innovative Drugs Act (draft) - Incentives for the development of pediatric oncology drugs - The Regenerative Medicine Regulatory Improvement Act (discussion draft) - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments - Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development - Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) - Incentives for the development of pediatric drugs - Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues - Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures - Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy - Proposed HRSA 340B program mega-guidance - Provisions related to 340B program - Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges - 340B Drug Discount Program policy issues - General FDA advocacy including sharing of truthful and non-misleading information about medicines with healthcare professionals - Prescription Drug User Fee Act (PDUFA) reauthorization - Biosimilar User Fee Act (BsUFA) reauthorization - Biologics Price Competition and Innovation Act (BPCIA) implementation issues - Biopharmaceutical and medical innovation policy issues - Drug development ecosystem policy issues - Drug cost and pricing policy issues - Expedited drug approval policy issues - Compassionate use policy issues - Biosimilar approval and reimbursement policy issues - Transparency policy issues - NIH Funding policy issues - Precision Medicine Initiative - Biomarker policy issues - Policy issues related to prescription drug abuse and secure disposal - Drug compounding policy issues - Prescription drug importation policy issues - Cancer Moonshot - Prescription drug take back policy issues - Clinical trial policy issues - Pediatric cancer policy issues - Cancer drug vial size policy issues - House Republican Health Proposal (A Better Way) - OTC Monograph Reform - Expanded access policy issues - Patient assistance program policy issues
Client expense: $640,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), Vice President of the U.S.
2016 · third_quarter · Health Issues
National Diabetes Prevention Program; Better care and treatment of people with diabetes under P.L. 111-148 Patient Protection and Affordable Care Act of 2009 (ACA) and P.L. 111-152 The Health Care & Education Affordability Reconciliation Act of 2010: Issues related to diabetes generally, and specifically diabetes screening, medical education and death certificate reporting (Catalyst for Better Diabetes), AHRQ and USPSTF diabetes screening standards; H.R. 1192 and S. 586 National Diabetes Clinical Care Commission Act of 2015; P.L. 114-10, Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) for Special Diabetes Program, CHIP, and childhood obesity; H.R. 1190 and S. 141 Protecting Seniors' Access to Medicare Act of 2015 (IPAB repeal); H.R. 2651 Eliminating Disparities in Diabetes Prevention, Access, and Care Act of 2015 (EDDPAC); cost of diabetes generally; S. 320 and H.R. 744 Medical Innovation Act of 2015; S. 2023 and H.R. 3513 Prescription Drug Affordability Act of 2015; H.R. 3742, Access to Marketplace Insurance Act and general allowance for certain third party payments of cost sharing.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · second_quarter · Health Issues
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 289: American Cures Act - Provisions related to National Institutes of Health (NIH) funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 480: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2016 - Provisions related to the reauthorization of the national controlled substance monitoring program S. 524: Comprehensive Addiction and Recovery Act of 2016 - Provisions related to opioids S. 800: Enhancing the Stature and Visibility of Medical Rehabilitation Research at the NIH Act - Issues related to the biopharmaceutical industry S. 849: Advancing Research for Neurological Diseases Act of 2016 - Provisions related to research on neurological diseases S. 1077: Advancing Breakthrough Devices for Patients Act of 2016 - Issues related to the biopharmaceutical industry S. 1101: Medical Electronic Data Technology Enhancement for Consumers' Health Act - Provisions related to regulation of software S. 1455: Recovery Enhancement for Addiction Treatment Act - Provisions related to opioids S. 1597: Patient-Focused Impact Assessment Act of 2016 - Provisions related to patient-focused drug development S. 1622: FDA Device Accountability Act of 2016 - Issues related to the biopharmaceutical industry S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: Combination Product Regulatory Fairness Act of 2016 - Provisions related to improvements in the regulation of combination drug-device products S. 1878: Advancing Hope Act of 2016 - Provisions related to pediatric cancer and other pediatric diseases S. 2014: Next Generation Researchers Act - Provisions related to NIH promoting new research. S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to importation S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2016 - Provisions related to rare disease treatment S. 2055: Medical Countermeasure Innovation Act of 2016 - Provisions related to priority review vouchers S. 2256: Co-Prescribing Saves Lives Act of 2015 - Provisions related to co-prescribing of opioids and reversal agents S. 2388: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2015 - Provisions related to reciprocity of drug approvals S. 2511: Improving Health Information Technology Act - Provisions related to health information technology (HIT) S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act - Provisions related to priority review vouchers S. 2615: Increasing Competition in Pharmaceuticals Act - Provisions related to FDA review of generic drugs and study on risk evaluation and mitigation strategies (REMS) program S. 2624: National Biomedical Research Act - Provisions related to mandatory funding for NIH and FDA S. 2680: Mental Health Reform Act of 2016 - Provisions related to mental health issues S. 2689: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments S. 2700: FDA and NIH Workforce Modernization Act - Provisions related to FDA and NIH S. 2713: Advancing Precision Medicine Act of 2016 - Provisions related to data sharing and security S. 2742: Promoting Biomedical Research and Public Health for Patients Act - Issues related to the biopharmaceutical industry S. 2912: A bill to authorize the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law, and for other purposes - Provisions related to use of unapproved medical products by patients with a terminal illness S. 3056: CREATES Act of 2016 - Provisions related to access to samples of prescription drugs H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 1538: Compassionate Access, Research Expansion, and Respect States (CARERS) Act of 2015 - Provisions related to regulation of marijuana and impact on medical research H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2805: Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 - Provisions related to the treatment of heroin and prescription opioid abuse H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing H.R. 3012: Right to Try Act of 2015 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 3250: DXM Abuse Prevention Act of 2015 - Issues related to prescription drug abuse H.R. 3381: Childhood Cancer STAR Act - Provisions related to expanded access and other issues H.R. 4762: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments H.R. 4784: Lower Drug Costs Through Competition Act - Provisions related to generic drugs and priority review vouchers; REMS study; and tropical disease product applications H.R. 5046: Comprehensive Opioid Abuse Reduction Act of 2016 - Provisions related to opioids H.R. 5127: Curb Opioid Abuse By Advancing Technology Act of 2016 - Provisions related to opioids Kids Innovative Drugs Act (draft) The Regenerative Medicine Regulatory Improvement Act (discussion draft) - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances Drug Supply Chain Security Act policy issues Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Proposed HRSA 340B program mega-guidance - Provisions related to 340B program Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges 340B Drug Discount Program policy issues General FDA advocacy including sharing of truthful and non-misleading information about medicines with healthcare professionals Prescription Drug User Fee Act (PDUFA) negotiation and reauthorization Biologics Price Competition and Innovation Act (BPCIA) implementation issues Biopharmaceutical and medical innovation policy issues Drug development ecosystem policy issues Drug cost and pricing policy issues Expedited drug approval policy issues Compassionate use policy issues Biosimilar approval and reimbursement policy issues Transparency policy issues NIH Funding policy issues Precision Medicine Initiative Biomarker policy issues Policy issues related to prescription drug abuse and secure disposal Drug compounding policy issues Prescription drug importation policy issues Cancer Moonshot Prescription drug take back policy issues Clinical trial policy issues Pediatric cancer policy issues Cancer drug vial size policy issues House Republican Health Proposal (A Better Way)
Client expense: $4,550,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Natl Security Council (NSC), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)
2016 · third_quarter · Health Issues
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 289: American Cures Act - Provisions related to National Institutes of Health (NIH) funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 524: Comprehensive Addiction and Recovery Act of 2016 - Provisions related to opioids S. 1077: Advancing Breakthrough Devices for Patients Act of 2016 - Issues related to the biopharmaceutical industry S. 1597: Patient-Focused Impact Assessment Act of 2016 - Provisions related to patient-focused drug development S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: Combination Product Regulatory Fairness Act of 2016 - Provisions related to improvements in the regulation of combination drug-device products S. 1878: Advancing Hope Act of 2016 - Provisions related to pediatric cancer and other pediatric diseases S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act - Provisions related to priority review vouchers S. 2615: Increasing Competition in Pharmaceuticals Act - Provisions related to FDA review of generic drugs and study on risk evaluation and mitigation strategies (REMS) program S. 2680: Mental Health Reform Act of 2016 - Provisions related to mental health issues S. 2689: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments S. 2700: FDA and NIH Workforce Modernization Act - Provisions related to FDA and NIH S. 2912: Trickett Wendler Right to Try Act of 2016 - A bill to authorize the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law, and for other purposes - Provisions related to use of unapproved medical products by patients with a terminal illness S. 3056: CREATES Act of 2016 - Provisions related to access to samples of prescription drugs S. 3239: RACE for Children Act - Provisions related to pediatric studies S. 3335: Fair Accountability and Innovative Research (FAIR) Drug Pricing Act - Provisions relating to transparency H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 1538: Compassionate Access, Research Expansion, and Respect States (CARERS) Act of 2015 - Provisions related to regulation of marijuana and impact on medical research H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2805: Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 - Provisions related to the treatment of heroin and prescription opioid abuse H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 or FAST Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing H.R. 3012: Right to Try Act of 2015 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 3381: Childhood Cancer STAR Act - Provisions related to expanded access and other issues H.R. 4762: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments H.R. 4784: Lower Drug Costs Through Competition Act - Provisions related to generic drugs and priority review vouchers; REMS study; and tropical disease product applications H.R. 5046: Comprehensive Opioid Abuse Reduction Act of 2016 - Provisions related to opioids H.R. 5122: A bill to prohibit further action on the proposed rule regarding testing of Medicare Part B prescription drug models H.R. 5858: The RACE for Children Act - Provisions related to pediatric studies H.R. 6043: Fair Accountability and Innovative Research (FAIR) Drug Pricing Act of 2016 - Provisions related to transparency H.R. 6174: Closing Loopholes for Orphan Drugs Act - Provisions relating to 340B discounts on orphan drugs Kids Innovative Drugs Act (draft) - Incentives for the development of pediatric oncology drugs The Regenerative Medicine Regulatory Improvement Act (discussion draft) - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) - Incentives for the development of pediatric drugs Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Proposed HRSA 340B program mega-guidance - Provisions related to 340B program Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges 340B Drug Discount Program policy issues General FDA advocacy including sharing of truthful and non-misleading information about medicines with healthcare professionals Prescription Drug User Fee Act (PDUFA) reauthorization Biosimilar User Fee Act (BsUFA) reauthorization Biologics Price Competition and Innovation Act (BPCIA) implementation issues Biopharmaceutical and medical innovation policy issues Drug development ecosystem policy issues Drug cost and pricing policy issues Expedited drug approval policy issues Compassionate use policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Transparency policy issues NIH Funding policy issues Precision Medicine Initiative Biomarker policy issues Policy issues related to prescription drug abuse and secure disposal Drug compounding policy issues Prescription drug importation policy issues Cancer Moonshot Prescription drug take back policy issues Clinical trial policy issues Pediatric cancer policy issues Cancer drug vial size policy issues House Republican Health Proposal (A Better Way) Expanded access policy issues
Client expense: $4,130,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)
2016 · third_quarter · Medical/Disease Research/Clinical Labs
H.R. 6, 21st Century Cures Act, (multiple provisions including incentives for innovation to help expedite novel treatments and cures, enhancements to FDA capacity and resources, and promotion of precision therapies, potential offsets) S. 320, The Medical Innovation Act. Legislation to authorize the collection of supplemental payments to increase congressional investments in medical research. Senate Innovations for Healthy Americans Act (text not yet available but likely multiple provisions similar to H.R. 6 including incentives for innovation to help expedite novel treatments and cures, enhancements to FDA capacity and resources, and promotion of precision therapies, potential offsets) S. 1878, Advancing Hope Act of 2015 legislation that amends the Federal Food, Drug, and Cosmetic Act to expand the priority review voucher program for rare pediatric diseases to include treatments for sickle cell disease and pediatric cancers.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · third_quarter · Medical/Disease Research/Clinical Labs
S. 320, The Medical Innovation Act. Legislation to authorize the collection of supplemental payments to increase congressional investments in medical research. H.R. 6, 21st Century Cures Act, (multiple provisions including incentives for innovation to help expedite novel treatments and cures, enhancements to FDA capacity and resources, and promotion of precision therapies, potential offsets) Senate Innovations for Healthy Americans Act (text not yet available but likely multiple provisions similar to H.R. 6 including incentives for innovation to help expedite novel treatments and cures, enhancements to FDA capacity and resources, and promotion of precision therapies, potential offsets) S. 1878, Advancing Hope Act of 2015 legislation that amends the Federal Food, Drug, and Cosmetic Act to expand the priority review voucher program for rare pediatric diseases to include treatments for sickle cell disease and pediatric cancers.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · third_quarter · Health Issues
H.R.5926/S.3040, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, FY2017, Medical Center related initiatives Medical Center related initiatives Biomedical innovation legislation (Senate draft) H.R.6, 21st Century Cures Act Cancer Moonshot Initiative Monitor the following: H.R.3291, Medicare Crosswalk Hospital Code Development Act of 2015, generally H.R.3292, Medicare IME Pool Act of 2015, generally H.R.3288, Strengthening DSH and Medicare Through Subsidy Recapture and Payment Reform Act of 2015, generally H.R.4273/S.2409, Medicare and Medicaid Improvements and Adjustments Act of 2015, Medicare reimbursement issues Concussion issues, generally S.2624, National Biomedical Research Act S.320, Medical Innovation Act of 2015 S.2646, Helping Families in Mental Health Crisis Act of 2015 S.2680, Mental Health Reform Act of 2016 Public Law 114-198, Comprehensive Addiction and Recovery Act of 2016 H.R.5273, Helping Hospitals Improve Patient Care Act of 2016
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · third_quarter · Health Issues
Cancer and medical research issues H.R.6, 21st Century Cures Act Biomedical innovation legislation (Senate draft) Big data issues H.R.4273/S.2409, Medicare and Medicaid Improvements and Adjustments Act of 2015, Medicare reimbursement issues Cancer Moonshot Initiative Precision Medicine Initiative S.2624, National Biomedical Research Act S.320, Medical Innovation Act of 2015
Client expense: Not reported · Firm income: $30,000
Government targets: Centers For Disease Control & Prevention (CDC), HOUSE OF REPRESENTATIVES, SENATE
2016 · third_quarter · Health Issues
National Diabetes Prevention Program; Better care and treatment of people with diabetes under P.L. 111-148 Patient Protection and Affordable Care Act of 2009 (ACA) and P.L. 111-152 The Health Care & Education Affordability Reconciliation Act of 2010: Issues related to diabetes generally, and specifically diabetes screening, medical education and death certificate reporting (Catalyst for Better Diabetes), AHRQ and USPSTF diabetes screening standards; diabetes issues in Healthy People 2020 and the Office of Disease Prevention and Health Promotion (ODPHP); H.R. 1192 and S. 586 National Diabetes Clinical Care Commission Act of 2015; P.L. 114-10, Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) for Special Diabetes Program, CHIP, and childhood obesity; S. 84 and H.R. 3658 Gestational Diabetes Act of 2015; H.R. 1190 and S. 141 Protecting Seniors' Access to Medicare Act of 2015 (IPAB repeal); H.R. 2651 Eliminating Disparities in Diabetes Prevention, Access, and Care Act of 2015 (EDDPAC); cost of diabetes generally; S. 320 and H.R. 744 Medical Innovation Act of 2015; S. 2023 and H.R. 3513 Prescription Drug Affordability Act of 2015; H.R. 3742, Access to Marketplace Insurance Act and general allowance for certain third party payments of cost sharing; Congressional recognition of World Hemophilia Day and Growth Awareness Week.
Client expense: $590,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Indian Health Service, Labor, Dept of (DOL), Natl Institutes of Health (NIH), SENATE, Treasury, Dept of
2016 · second_quarter · Health Issues
Implementation of Patient Protection & Affordable Health Care Act (P.L. 111-148) and Implementation of Health Care and Education Reconciliation Act (P.L. 111-152) 340B issues and legislative reform proposals Issues related to importation of prescription drugs, including those contained in S. 122, Safe and Affordable Drugs from Canada Act of 2015 Health technology assessment of orphan drugs Sequestration of FDA user fees H.R. 1376, Patient Choice Act of 2015 H.R. 790, Compassionate Freedom of Choice Act of 2015 H.R. 1600, Patients' Access to Treatments Act of 2015 21st Century Cures/Innovation initiatives including H.R. 6, 21st Century Cures Act and the Innovation for Healthier Americans Initiative, including the following: S. 2055, The Medical Countermeasures Innovation Act of 2015; S. 2512, Adding Zika Virus to the FDA Priority Review Voucher Program Act; S. 2030, The Advancing Targeted Therapies for Rare Diseases Act of 2015; S. 849, Advancing Research for Neurological Diseases Act of 2015; S. 2700, FDA and NIH Workfroces Authorities Modernization Act H.R. 909, Andrea Sloan CURE Act S. 1421 and H.R.971, Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 Implementation of the FDA Safety and Innovation Act (FDASIA) (Pub. L. 112-144) Regulation of innovative biological products for neurodegenerative diseases Issues and policies related to implementation of Orphan Drug Act and orphan drug development S. 320, Medical Innovation Act H.R. 744, Medical Innovation Act S. 2615, Increasing Competition in Pharmaceuticals Act H.R. 1130, Chronic Kidney Disease Improvement in Research and Treatment Act of 2015 S. 598, Chronic Kidney Disease Improvement in Research and Treatment Act of 2015 H.R. 1078, Food and Drug Administration Safety Over Sequestration Act of 2015 H.R. 1531 and S.1878, Advancing Hope Act of 2015 Implementation of newborn screening programs Issues and policies related to biosimilars exclusivity period Issues and policies related to biosimilars FDA guidance Issues and policies related to FDA oversight and management Issues and policies related to expanded access programs Issues and policies related to patient involvement with FDA decision making S. 289 and H.R. 2104, American Cures Act Legislation pertaining to FDA priority review vouchers, generally Legislation pertaining to the applicability of the ACA tax carve out for non-orphan drug designated drugs, generally, including H.R. 3678, Preserving Access to Orphan Drugs Act of 2015 H.R. 3618 and S. 1906, Orphan Drug Fairness Act Issues related to the value of prescription medicines, generally, and including S. 2023, Prescription Drug Affordability Act of 2015 Drug shortage issues Issues related to health care transparency S. 2055, Medical Countermeasure Innovation Act of 2016 H.R. 3299, Strengthening Public Health Emergency Response Act S. 2700, FDA and NIH Workforce Authorities Modernization Act S. 2713, Advancing Precision Medicine Act of 2016 S. 2745, Advancing NIH Strategic Planning and Representation in Medical Research Act S. 2742, Promoting Biomedical Research and Public Health for Patients Act S. 3239, H.R. 5858, The RACE for Children Act S. 2689, The REGROW Act
Client expense: $280,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2016 · second_quarter · Health Issues
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 2055 - the Medical Countermeasure Innovation Act of 2015 S. 289: American Cures Act - Provisions related to NIH funding S. 320: Medical Innovation Act of 2015 - Provisions related to National Institutes of Health (NIH) funding and covered manufacturer supplemental fees S. 480: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2016 S. 524: Comprehensive Addiction and Recovery Act of 2016 - Provisions related to opioids S. 800: Enhancing the Stature and Visibility of Medical Rehabilitation Research at the NIH Act S. 849: Advancing Research for Neurological Diseases Act of 2016 - Provisions related to research on neurological diseases S. 1077: Advancing Breakthrough Devices for Patients Act of 2016 S. 1101: Medical Electronic Data Technology Enhancement for Consumers' Health Act - Provisions related to regulation of software S. 1455: Recovery Enhancement for Addiction Treatment Act - Provisions related to opioids S. 1597: Patient-Focused Impact Assessment Act of 2016 - Provisions related to patient-focused drug development S. 1622: FDA Device Accountability Act of 2016 S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: Combination Product Regulatory Fairness Act of 2016 - Provisions related to improvements in the regulation of combination drug-device products S. 1878: Advancing Hope Act of 2016 - Provisions related to pediatric cancer and other pediatric diseases S. 2014: Next Generation Researchers Act - Provisions related to NIH promoting new research. S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to importation S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2016 - Provisions related to rare disease treatment S. 2055: Medical Countermeasure Innovation Act of 2016 S. 2256: Co-Prescribing Saves Lives Act of 2015 - Provisions related to co-prescribing of opioids and reversal agents S. 2388: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2015 - Provisions related to reciprocity of drug approvals S. 2511: Improving Health Information Technology Act - Provisions related to health information technology (HIT) S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act - Provisions related to priority review vouchers S. 2615: Increasing Competition in Pharmaceuticals Act - Provisions related to FDA review of generic drugs and study on risk evaluation and mitigation strategies (REMS) program S. 2624: National Biomedical Research Act - Provisions related to mandatory funding for NIH and FDA S. 2680: Mental Health Reform Act of 2016 - Provisions related to mental health issues S. 2689: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments S. 2700: FDA and NIH Workforce Modernization Act - Provisions related to FDA and NIH S. 2713: Advancing Precision Medicine Act of 2016 - Provisions related to data sharing and security S. 2742: Promoting Biomedical Research and Public Health for Patients Act S. 2912: A bill to authorize the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law, and for other purposes - Provisions related to use of unapproved medical products by patients with a terminal illness S. 3056: CREATES Act of 2016 - Provisions related to access to samples of prescription drugs H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 1538: Compassionate Access, Research Expansion, and Respect States (CARERS) Act of 2015 - Provisions related to regulation of marijuana and impact on legitimate medical research H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2805: Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 - Provisions related to the treatment of heroin and prescription opioid abuse H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing H.R. 3012: Right to Try Act of 2015 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 3250: DXM Abuse Prevention Act of 2015 HR. 3299 - the Strengthening Public Health Emergency Response Act of 2015 H.R. 3381: Childhood Cancer STAR Act - Provisions related to expanded access and other issues H.R. 4762: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments H.R. 4784: Lower Drug Costs Through Competition Act - Provisions related to generic drugs and priority review vouchers; REMS study; and tropical disease product applications H.R. 5046: Comprehensive Opioid Abuse Reduction Act of 2016 - Provisions related to opioids H.R. 5127: Curb Opioid Abuse By Advancing Technology Act of 2016 - Provisions related to opioids Other: - Kids Innovative Drugs Act (draft) - The Regenerative Medicine Regulatory Improvement Act (discussion draft) - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments - Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development - ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances - Drug Supply Chain Security Act policy issues - Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) - Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues - Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures - Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy - Proposed HRSA 340B program mega-guidance - Provisions related to 340B program Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges - 340B Drug Discount Program policy issues - General FDA advocacy including sharing of truthful and non-misleading information about medicines with healthcare professionals - Prescription Drug User Fee Act (PDUFA) negotiation and reauthorization - Biologics Price Competition and Innovation Act (BPCIA) implementation issues - Biopharmaceutical and medical innovation policy issues - Drug development ecosystem policy issues - Drug cost and pricing policy issues - Expedited drug approval policy issues - Compassionate use policy issues - Biosimilar approval and reimbursement policy issues - Transparency policy issues - NIH Funding policy issues - Precision Medicine Initiative - Policy issues related to prescription drug abuse and secure disposal - Drug compounding policy issues - Prescription drug importation policy issues - Cancer Moonshot - Prescription drug take back policy issues - Clinical trial policy issues - Pediatric cancer policy issues - Cancer drug vial sizes policy issues - House Republican Health Proposal (A Better Way)
Client expense: $1,070,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Defense, Dept of (DOD), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)
2016 · second_quarter · Health Issues
National Diabetes Prevention Program; Better care and treatment of people with diabetes under P.L. 111-148 Patient Protection and Affordable Care Act of 2009 (ACA) and P.L. 111-152 The Health Care & Education Affordability Reconciliation Act of 2010: Issues related to diabetes generally, and specifically diabetes screening, medical education and death certificate reporting (Catalyst for Better Diabetes), AHRQ and USPSTF diabetes screening standards; H.R. 1192 and S. 586 National Diabetes Clinical Care Commission Act of 2015; P.L. 114-10, Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) for Special Diabetes Program, CHIP, and childhood obesity; S. 84 and H.R. 3658 Gestational Diabetes Act of 2015; H.R. 1190 and S. 141 Protecting Seniors' Access to Medicare Act of 2015 (IPAB repeal); H.R. 2651 Eliminating Disparities in Diabetes Prevention, Access, and Care Act of 2015 (EDDPAC); cost of diabetes generally; S. 320 and H.R. 744 Medical Innovation Act of 2015; S. 2023 and H.R. 3513 Prescription Drug Affordability Act of 2015; H.R. 3742, Access to Marketplace Insurance Act and general allowance for certain third party payments of cost sharing.
Client expense: Not reported · Firm income: $70,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)
2016 · second_quarter · Health Issues
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 289: American Cures Act - Provisions related to National Institutes of Health (NIH) funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 480: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2016 - Provisions related to the reauthorization of the national controlled substance monitoring program S. 524: Comprehensive Addiction and Recovery Act of 2016 - Provisions related to opioids S. 800: Enhancing the Stature and Visibility of Medical Rehabilitation Research at the NIH Act - Issues related to the biopharmaceutical industry S. 849: Advancing Research for Neurological Diseases Act of 2016 - Provisions related to research on neurological diseases S. 1077: Advancing Breakthrough Devices for Patients Act of 2016 - Issues related to the biopharmaceutical industry S. 1101: Medical Electronic Data Technology Enhancement for Consumers' Health Act - Provisions related to regulation of software S. 1455: Recovery Enhancement for Addiction Treatment Act - Provisions related to opioids S. 1597: Patient-Focused Impact Assessment Act of 2016 - Provisions related to patient-focused drug development S. 1622: FDA Device Accountability Act of 2016 - Issues related to the biopharmaceutical industry S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: Combination Product Regulatory Fairness Act of 2016 - Provisions related to improvements in the regulation of combination drug-device products S. 1878: Advancing Hope Act of 2016 - Provisions related to pediatric cancer and other pediatric diseases S. 2014: Next Generation Researchers Act - Provisions related to NIH promoting new research. S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to importation S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2016 - Provisions related to rare disease treatment S. 2055: Medical Countermeasure Innovation Act of 2016 - Provisions related to priority review vouchers S. 2256: Co-Prescribing Saves Lives Act of 2015 - Provisions related to co-prescribing of opioids and reversal agents S. 2388: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2015 - Provisions related to reciprocity of drug approvals S. 2511: Improving Health Information Technology Act - Provisions related to health information technology (HIT) S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act - Provisions related to priority review vouchers S. 2615: Increasing Competition in Pharmaceuticals Act - Provisions related to FDA review of generic drugs and study on risk evaluation and mitigation strategies (REMS) program S. 2624: National Biomedical Research Act - Provisions related to mandatory funding for NIH and FDA S. 2680: Mental Health Reform Act of 2016 - Provisions related to mental health issues S. 2689: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments S. 2700: FDA and NIH Workforce Modernization Act - Provisions related to FDA and NIH S. 2713: Advancing Precision Medicine Act of 2016 - Provisions related to data sharing and security S. 2742: Promoting Biomedical Research and Public Health for Patients Act - Issues related to the biopharmaceutical industry S. 2912: A bill to authorize the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law, and for other purposes - Provisions related to use of unapproved medical products by patients with a terminal illness S. 3056: CREATES Act of 2016 - Provisions related to access to samples of prescription drugs H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 1538: Compassionate Access, Research Expansion, and Respect States (CARERS) Act of 2015 - Provisions related to regulation of marijuana and impact on medical research H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2805: Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 - Provisions related to the treatment of heroin and prescription opioid abuse H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing H.R. 3012: Right to Try Act of 2015 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 3250: DXM Abuse Prevention Act of 2015 - Issues related to prescription drug abuse H.R. 3381: Childhood Cancer STAR Act - Provisions related to expanded access and other issues H.R. 4762: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments H.R. 4784: Lower Drug Costs Through Competition Act - Provisions related to generic drugs and priority review vouchers; REMS study; and tropical disease product applications H.R. 5046: Comprehensive Opioid Abuse Reduction Act of 2016 - Provisions related to opioids H.R. 5127: Curb Opioid Abuse By Advancing Technology Act of 2016 - Provisions related to opioids Kids Innovative Drugs Act (draft) The Regenerative Medicine Regulatory Improvement Act (discussion draft) - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances Drug Supply Chain Security Act policy issues Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Proposed HRSA 340B program mega-guidance - Provisions related to 340B program Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges 340B Drug Discount Program policy issues General FDA advocacy including sharing of truthful and non-misleading information about medicines with healthcare professionals Prescription Drug User Fee Act (PDUFA) negotiation and reauthorization Biologics Price Competition and Innovation Act (BPCIA) implementation issues Biopharmaceutical and medical innovation policy issues Drug development ecosystem policy issues Drug cost and pricing policy issues Expedited drug approval policy issues Compassionate use policy issues Biosimilar approval and reimbursement policy issues Transparency policy issues NIH Funding policy issues Precision Medicine Initiative Biomarker policy issues Policy issues related to prescription drug abuse and secure disposal Drug compounding policy issues Prescription drug importation policy issues Cancer Moonshot Prescription drug take back policy issues Clinical trial policy issues Pediatric cancer policy issues Cancer drug vial size policy issues House Republican Health Proposal (A Better Way)
Client expense: $5,820,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Natl Security Council (NSC), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)
2016 · second_quarter · Health Issues
S 318, HR 531 Accelerating Biomedical Research Act HR 744, S 320 Medical Innovation Act (Swear Jar bill) HR 777 Permanent Investment in Health Research Act HR 6 21st Century Cures S 289, HR 2104 American Cures Act HR 2101 Research for All Act S 1077 Advancing Breakthrough Devices for Patients HR 2337 To amend the Federal Food, Drug, and Cosmetic Act to authorize priority review for breakthrough devices HR 160 Protect Medical Innovation Act of 2015 (to repeal the ACA medical device tax) S2014 HR3466 Next Generation Researchers Act HR 3171 HR 3215 HR 3429 S 1917 legislation relating to the regulation of fetal tissue research HR639 Improving Regulatory Transparency for New Medical Therapies Act (signed into law) HR 2820 Stem Cell Therapeutic and Research Reauthorization Act of 2015 (signed into law) HR 2646 S1945 Helping Families in Mental Health Crisis Act of 2015 HR 3731, S 2030 Rare Disease Fund Act of 2015 HR 3729 Limit Fetal Tissue Research S 2141 Transparent Ratings on Usability and Security to Transform Information Technology Act of 2015 or TRUST It Act (with respect to health information technology) S 2624 National Biomedical Research Act S 1878 Advancing Hope Act of 2015 S 2512 Adding Zika Virus to the FDA Priority Review Voucher Program Act S 1101 Medical Electronic Data Technology Enhancement for Consumers' Health Act S 1767 Combination Product Regulatory Fairness Act of 2015 S 1597 Patient-Focused Impact Assessment Act of 2015 S 2055 Medical Countermeasure Innovation Act of 2016 S 1945 Mental Health Reform Act of 2015 S 1622 FDA Device Accountability Act S 849 Advancing Research for Neurological Diseases Act of 2015 S 800 Enhancing the Stature and Visibility of Medical Rehabilitation Research at the NIH Act S 2700 FDA and NIH Workforce Authorities Modernization Act S 2713 Advancing Precision Medicine Act of 2016 S 2745 NIH Strategic Plan and Inclusion in Clinical Research S 2472 Promoting Biomedical Research and Public Health for Patients Act (to reduce regulatory burden on NIH-funded researchers)
Client expense: $15,681 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · second_quarter · Medical/Disease Research/Clinical Labs
S. 320, The Medical Innovation Act. Legislation to authorize the collection of supplemental payments to increase congressional investments in medical research. H.R. 6, 21st Century Cures Act, (multiple provisions including incentives for innovation to help expedite novel treatments and cures, enhancements to FDA capacity and resources, and promotion of precision therapies, potential offsets) Senate Innovations for Healthy Americans Act (text not yet available but likely multiple provisions similar to H.R. 6 including incentives for innovation to help expedite novel treatments and cures, enhancements to FDA capacity and resources, and promotion of precision therapies, potential offsets)
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · second_quarter · Medical/Disease Research/Clinical Labs
H.R. 6, 21st Century Cures Act, (multiple provisions including incentives for innovation to help expedite novel treatments and cures, enhancements to FDA capacity and resources, and promotion of precision therapies, potential offsets) S. 320, The Medical Innovation Act. Legislation to authorize the collection of supplemental payments to increase congressional investments in medical research. Senate Innovations for Healthy Americans Act (text not yet available but likely multiple provisions similar to H.R. 6 including incentives for innovation to help expedite novel treatments and cures, enhancements to FDA capacity and resources, and promotion of precision therapies, potential offsets)
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · second_quarter · Health Issues
S.3040, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, FY2017, Medical Center related initiatives H.R.6, 21st Century Cures Act, Medical Center related initiatives Monitor the following: H.R.3291, Medicare Crosswalk Hospital Code Development Act of 2015, generally H.R.3292, Medicare IME Pool Act of 2015, generally H.R.3288, Strengthening DSH and Medicare Through Subsidy Recapture and Payment Reform Act of 2015, generally H.R.4273/S.2409, Medicare and Medicaid Improvements and Adjustments Act of 2015, Medicare reimbursement issues Concussion issues, generally S. 2030, The Advancing Targeted Therapies for Rare Diseases Act of 2015 S. 1622, The FDA Device Accountability Act of 2015 S. 2014, Next Generation Researchers Act S. 800, The Enhancing the Stature and Visibility of Medical Rehabilitation Research at NIH Act S. 849, Advancing Research for Neurological Diseases Act of 2015 S. 2503, Preventing Superbugs and Protecting Patients Act S. 2511, Improving Health Information Technology S. 1878, The Advancing Hope Act of 2015 S. 1077, The Advancing Breakthrough Medical Devices for Patients Act of 2015 S. 1101, The Medical Electronic Data Technology Enhancement for Consumers Health Act S. 2055, The Medical Countermeasures Innovation Act of 2015 S. 1767, The Combination Products Innovation Act of 2015 S. 1597, Patient Focused Impact Assessment Act of 2015 S. 2512, Adding Zika Virus to the FDA Priority Review Voucher Program Act S. 2700, FDA and NIH Workforce Authorities Modernization Act S. 185, Promise for Antibiotics and Therapeutics for Health Act S. 2713, Advancing Precision Medicine Act of 2016 S. 2745, Advancing NIH Strategic Planning and Representation in Medical Research Act S. 2742, Promoting Biomedical Research and Public Health for Patients Act S.2624, National Biomedical Research Act S.320, Medical Innovation Act of 2015 S.2646, Helping Families in Mental Health Crisis Act of 2015 S.2680, Mental Health Reform Act of 2016 S.524, Comprehensive Addiction and Recovery Act of 2016 H.R.5273, Helping Hospitals Improve Patient Care Act of 2016
Client expense: Not reported · Firm income: $30,000
Government targets: Defense, Dept of (DOD), HOUSE OF REPRESENTATIVES, SENATE
2016 · second_quarter · Health Issues
Cancer research issues H.R.6, 21st Century Cures Act, Medical research issues Big data issues H.R.4273/S.2409, Medicare and Medicaid Improvements and Adjustments Act of 2015, Medicare reimbursement issues Cancer Moonshot Initiative Precision Medicine S.2624, National Biomedical Research Act S.320, Medical Innovation Act of 2015 S. 2030, The Advancing Targeted Therapies for Rare Diseases Act of 2015 S. 1622, The FDA Device Accountability Act of 2015 S. 2014, Next Generation Researchers Act S. 800, The Enhancing the Stature and Visibility of Medical Rehabilitation Research at NIH Act S. 849, Advancing Research for Neurological Diseases Act of 2015 S. 2503, Preventing Superbugs and Protecting Patients Act S. 2511, Improving Health Information Technology S. 1878, The Advancing Hope Act of 2015 S. 1077, The Advancing Breakthrough Medical Devices for Patients Act of 2015 S. 1101, The Medical Electronic Data Technology Enhancement for Consumers Health Act S. 2055, The Medical Countermeasures Innovation Act of 2015 S. 1767, The Combination Products Innovation Act of 2015 S. 1597, Patient Focused Impact Assessment Act of 2015 S. 2512, Adding Zika Virus to the FDA Priority Review Voucher Program Act S. 2700, FDA and NIH Workforce Authorities Modernization Act S. 185, Promise for Antibiotics and Therapeutics for Health Act S. 2713, Advancing Precision Medicine Act of 2016 S. 2745, Advancing NIH Strategic Planning and Representation in Medical Research Act S. 2742, Promoting Biomedical Research and Public Health for Patients Act
Client expense: Not reported · Firm income: $30,000
Government targets: Centers For Disease Control & Prevention (CDC), HOUSE OF REPRESENTATIVES, SENATE
2016 · second_quarter · Health Issues
National Diabetes Prevention Program; Better care and treatment of people with diabetes under P.L. 111-148 Patient Protection and Affordable Care Act of 2009 (ACA) and P.L. 111-152 The Health Care & Education Affordability Reconciliation Act of 2010: Issues related to diabetes generally, and specifically diabetes screening, medical education and death certificate reporting (Catalyst for Better Diabetes), AHRQ and USPSTF diabetes screening standards; diabetes issues in Healthy People 2020 and the Office of Disease Prevention and Health Promotion (ODPHP); H.R. 1192 and S. 586 National Diabetes Clinical Care Commission Act of 2015; P.L. 114-10, Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) for Special Diabetes Program, CHIP, and childhood obesity; S. 84 and H.R. 3658 Gestational Diabetes Act of 2015; H.R. 1190 and S. 141 Protecting Seniors' Access to Medicare Act of 2015 (IPAB repeal); H.R. 2651 Eliminating Disparities in Diabetes Prevention, Access, and Care Act of 2015 (EDDPAC); cost of diabetes generally; S. 320 and H.R. 744 Medical Innovation Act of 2015; S. 2023 and H.R. 3513 Prescription Drug Affordability Act of 2015; H.R. 3742, Access to Marketplace Insurance Act and general allowance for certain third party payments of cost sharing; Congressional recognition of World Hemophilia Day
Client expense: $690,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Indian Health Service, Labor, Dept of (DOL), Natl Institutes of Health (NIH), SENATE, Treasury, Dept of
2016 · first_quarter · Health Issues
National Diabetes Prevention Program; Better care and treatment of people with diabetes under P.L. 111-148 Patient Protection and Affordable Care Act of 2009 (ACA) and P.L. 111-152 The Health Care & Education Affordability Reconciliation Act of 2010: Issues related to diabetes generally, and specifically diabetes screening, medical education and death certificate reporting (Catalyst for Better Diabetes), AHRQ and USPSTF diabetes screening standards; diabetes issues in Healthy People 2020 and the Office of Disease Prevention and Health Promotion (ODPHP); H.R. 1192 and S. 586 National Diabetes Clinical Care Commission Act of 2015; P.L. 114-10, Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) for Special Diabetes Program, CHIP, and childhood obesity; S. 84 and H.R. 3658 Gestational Diabetes Act of 2015; H.R. 1190 and S. 141 Protecting Seniors' Access to Medicare Act of 2015 (IPAB repeal); H.R. 2651 Eliminating Disparities in Diabetes Prevention, Access, and Care Act of 2015 (EDDPAC); cost of diabetes generally; S. 320 and H.R. 744 Medical Innovation Act of 2015; S. 2023 and H.R. 3513 Prescription Drug Affordability Act of 2015; H.R. 3742, Access to Marketplace Insurance Act and general allowance for certain third party payments of cost sharing; Congressional recognition of World Hemophilia Day
Client expense: $970,000 · Firm income: Not reported
2016 · first_quarter · Health Issues
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 289: American Cures Act - Provisions related to NIH funding S. 320: Medical Innovation Act of 2015 - Provisions related to National Institutes of Health (NIH) funding and covered manufacturer supplemental fees S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to Drug Enforcement Administration (DEA) scheduling S. 483: Ensuring Patient Access and Effective Drug Enforcement Act of 2016 - Provisions related to registration under the Controlled Substances Act (CSA) S. 524: Comprehensive Addiction and Recovery Act of 2016 - Provisions related to opioids S. 683: Compassionate Access, Research Expansion, and Respect States (CARERS) Act of 2015 - Provisions related to regulation of marijuana and impact on legitimate medical research S. 849: Advancing Research for Neurological Diseases Act of 2016 - Provisions related to research on neurological diseases S. 1128: Preserving Access to Orphan Drugs Act - Provisions related to orphan drug tax (113th Congress) S. 1455: Recovery Enhancement for Addiction Treatment Act - Provisions related to opioids S. 1597: Patient-Focused Impact Assessment Act of 2016 - Provisions related to patient-focused drug development S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: Combination Product Regulatory Fairness Act of 2016 - Provisions related to improvements in the regulation of combination drug-device products S. 1878: Advancing Hope Act of 2016 - Provisions related to pediatric cancer and other pediatric diseases S. 2014: Next Generation Researchers Act - Provisions related to NIH promoting new research. S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to importation S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2016 - Provisions related to rare disease treatment S. 2055 - the Medical Countermeasure Innovation Act of 2015 S. 2256: Co-Prescribing Saves Lives Act of 2015 - Provisions related to co-prescribing S. 2388: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2015 - Provisions related to reciprocity of drug approvals S. 2503: Preventing Superbugs and Protecting Patients Act - Provisions related to antibiotic development S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act - Provisions related to priority review vouchers S. 2615: Increasing Competition in Pharmaceuticals Act - Provisions related to FDA review of generic drugs and study on risk evaluation and mitigation strategies (REMS) program S. 2624: National Biomedical Research Act - Provisions related to mandatory funding for NIH and FDA S. 2680: Mental Health Reform Act of 2016 - Provisions related to mental health issues S. 2689: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments S. 2700: FDA and NIH Workforce Modernization Act - Provisions related to FDA and NIH H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 1455: Speeding Access to Already Approved Pharmaceuticals Act of 2015 - Provisions requiring FDA to expedite review of pharmaceuticals that are approved for marketing in the European Union H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 1538: Compassionate Access, Research Expansion, and Respect States (CARERS) Act of 2015 - Provisions related to regulation of marijuana and impact on legitimate medical research H.R. 1576: Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015 - Provisions related to the study of regulatory challenges for the approval of complex generic drugs H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2745: Standard Merger and Acquisition Reviews Through Equal Rules Act of 2015; Motion to Recommit H.R. 2745 with Instructions - Provisions related to prescription drug costs H.R. 2805: Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 - Provisions related to the treatment of heroin and prescription opioid abuse H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing HR. 3299 - the Strengthening Public Health Emergency Response Act of 2015 H.R. 3537: Synthetic Drug Control Act of 2015 - Provisions related to amending the Controlled Substances Analogue Act and the legislative scheduling of molecules used in legitimate medical research H.R. 3762: Restoring Americans Healthcare Freedom Reconciliation Act of 2015 - Provisions related to amending and withdrawing funding from the Affordable Care Act H.R. 4365: Protecting Patient Access to Emergency Medications Act of 2016 - Provisions related to controlled substances H.R. 4762: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments H.R. 4784: Lower Drug Costs Through Competition Act - Provisions related to generic drugs and priority review vouchers; REMS study; and tropical disease product applications The Regenerative Medicine Regulatory Improvement Act (discussion draft) - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances Breakpoints (discussion draft) - Provisions relating to the updating of breakpoint information for antibiotics on an FDA managed website Drug Supply Chain Security Act policy issues Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability; Proposed rules [CMS-2390-P] Provisions related to 340B program Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Proposed HRSA 340B program mega-guidance - Provisions related to 340B program Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges Physician Payment Sunshine Act implementation issues, such as Open Payments System issues 340B Drug Discount Program policy issues General FDA advocacy including sharing of truthful and non-misleading information about medicines with healthcare professionals Prescription Drug User Fee Act (PDUFA) negotiation and reauthorization Biologics Price Competition and Innovation Act (BPCIA) implementation issues Generic Drug User Fee Act (GDUFA) policy issues Biopharmaceutical and medical innovation policy issues Drug development ecosystem policy issues Drug cost and pricing policy issues Expedited drug approval policy issues Compassionate use policy issues Biosimilar approval and reimbursement policy issues Transparency policy issues NIH Funding policy issues Precision Medicine Initiative Biomarker policy issues Policy issues related to prescription drug abuse and secure disposal Antibiotics development policy issues Drug compounding policy issues Nomination of Robert Califf to FDA Commissioner Prescription drug importation policy issues Cancer Moonshot
Client expense: $1,490,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), Vice President of the U.S.
2016 · first_quarter · Health Issues
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 289: American Cures Act - Provisions related to NIH funding S. 320: Medical Innovation Act of 2015 - Provisions related to National Institutes of Health (NIH) funding and covered manufacturer supplemental fees S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to Drug Enforcement Administration (DEA) scheduling S. 483: Ensuring Patient Access and Effective Drug Enforcement Act of 2016 - Provisions related to registration under the Controlled Substances Act (CSA) S. 524: Comprehensive Addiction and Recovery Act of 2016 - Provisions related to opioids S. 683: Compassionate Access, Research Expansion, and Respect States (CARERS) Act of 2015 - Provisions related to regulation of marijuana and impact on legitimate medical research S. 849: Advancing Research for Neurological Diseases Act of 2016 - Provisions related to research on neurological diseases S. 1128: Preserving Access to Orphan Drugs Act of 2013 - Provisions related to orphan drug tax (113th Congress) S. 1455: Recovery Enhancement for Addiction Treatment Act - Provisions related to opioids S. 1597: Patient-Focused Impact Assessment Act of 2016 - Provisions related to patient-focused drug development S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: Combination Product Regulatory Fairness Act of 2016 - Provisions related to improvements in the regulation of combination drug-device products S. 1878: Advancing Hope Act of 2016 - Provisions related to pediatric cancer and other pediatric diseases S. 2014: Next Generation Researchers Act - Provisions related to NIH promoting new research. S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to importation S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2016 - Provisions related to rare disease treatment S. 2256: Co-Prescribing Saves Lives Act of 2015 - Provisions related to co-prescribing of opioids and reversal agents S. 2388: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2015 - Provisions related to reciprocity of drug approvals S. 2503: Preventing Superbugs and Protecting Patients Act - Provisions related to antibiotic development S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act - Provisions related to priority review vouchers S. 2615: Increasing Competition in Pharmaceuticals Act - Provisions related to FDA review of generic drugs and study on risk evaluation and mitigation strategies (REMS) program S. 2624: National Biomedical Research Act - Provisions related to mandatory funding for NIH and FDA S. 2680: Mental Health Reform Act of 2016 - Provisions related to mental health issues S. 2689: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments S. 2700: FDA and NIH Workforce Modernization Act - Provisions related to FDA and NIH H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 1455: Speeding Access to Already Approved Pharmaceuticals Act of 2015 - Provisions requiring FDA to expedite review of pharmaceuticals that are approved for marketing in the European Union H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 1538: Compassionate Access, Research Expansion, and Respect States (CARERS) Act of 2015 - Provisions related to regulation of marijuana and impact on legitimate medical research H.R. 1576: Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015 - Provisions related to the study of regulatory challenges for the approval of complex generic drugs H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2745: Standard Merger and Acquisition Reviews Through Equal Rules Act of 2015; Motion to Recommit H.R. 2745 with Instructions - Provisions related to prescription drug costs H.R. 2805: Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 - Provisions related to the treatment of heroin and prescription opioid abuse H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing H.R. 3537: Synthetic Drug Control Act of 2015 - Provisions related to amending the Controlled Substances Analogue Act and the legislative scheduling of molecules used in legitimate medical research H.R. 3762: Restoring Americans Healthcare Freedom Reconciliation Act of 2015 - Provisions related to amending and withdrawing funding from the Affordable Care Act H.R. 4365: Protecting Patient Access to Emergency Medications Act of 2016 - Provisions related to controlled substances H.R. 4762: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments H.R. 4784: Lower Drug Costs Through Competition Act - Provisions related to generic drugs and priority review vouchers; REMS study; and tropical disease product applications The Regenerative Medicine Regulatory Improvement Act (discussion draft) - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances Breakpoints (discussion draft) - Provisions relating to the updating of breakpoint information for antibiotics on an FDA managed website Drug Supply Chain Security Act policy issues Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability; Proposed rules [CMS-2390-P] Provisions related to 340B program Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Proposed HRSA 340B program mega-guidance - Provisions related to 340B program Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges Physician Payment Sunshine Act implementation issues, such as Open Payments System issues 340B Drug Discount Program policy issues General FDA advocacy including sharing of truthful and non-misleading information about medicines with healthcare professionals Prescription Drug User Fee Act (PDUFA) negotiation and reauthorization Biologics Price Competition and Innovation Act (BPCIA) implementation issues Generic Drug User Fee Act (GDUFA) policy issues Biopharmaceutical and medical innovation policy issues Drug development ecosystem policy issues Drug cost and pricing policy issues Expedited drug approval policy issues Compassionate use policy issues Biosimilar approval and reimbursement policy issues Transparency policy issues NIH Funding policy issues Precision Medicine Initiative Biomarker policy issues Policy issues related to prescription drug abuse and secure disposal Antibiotics development policy issues Drug compounding policy issues Nomination of Robert Califf to FDA Commissioner Prescription drug importation policy issues Cancer Moonshot
Client expense: $5,950,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), Vice President of the U.S.
2016 · first_quarter · Health Issues
Implementation of Patient Protection & Affordable Health Care Act (P.L. 111-148) and Implementation of Health Care and Education Reconciliation Act (P.L. 111-152) 340B issues and legislative reform proposals Issues related to importation of prescription drugs, including those contained in S. 122, Safe and Affordable Drugs from Canada Act of 2015 Health technology assessment of orphan drugs Sequestration of FDA user fees H.R. 1376, Patient Choice Act of 2015 H.R. 790, Compassionate Freedom of Choice Act of 2015 H.R. 1600, Patients' Access to Treatments Act of 2015 21st Century Cures/Innovation initiatives including H.R. 6, 21st Century Cures Act and the Innovation for Healthier Americans Initiative, including the following: S. 2055, The Medical Countermeasures Innovation Act of 2015; S. 2512, Adding Zika Virus to the FDA Priority Review Voucher Program Act; S. 2030, The Advancing Targeted Therapies for Rare Diseases Act of 2015; S. 849, Advancing Research for Neurological Diseases Act of 2015; S. 2700, FDA and NIH Workfroces Authorities Modernization Act H.R. 909, Andrea Sloan CURE Act S. 1421 and H.R.971, Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 Implementation of the FDA Safety and Innovation Act (FDASIA) (Pub. L. 112-144) Regulation of innovative biological products for neurodegenerative diseases Issues and policies related to implementation of Orphan Drug Act and orphan drug development S. 320, Medical Innovation Act H.R. 744, Medical Innovation Act S. 2615, Increasing Competition in Pharmaceuticals Act H.R. 1130, Chronic Kidney Disease Improvement in Research and Treatment Act of 2015 S. 598, Chronic Kidney Disease Improvement in Research and Treatment Act of 2015 H.R. 1078, Food and Drug Administration Safety Over Sequestration Act of 2015 H.R. 1531 and S.1878, Advancing Hope Act of 2015 Implementation of newborn screening programs Issues and policies related to biosimilars exclusivity period Issues and policies related to biosimilars FDA guidance Issues and policies related to FDA oversight and management Issues and policies related to expanded access programs Issues and policies related to patient involvement with FDA decision making S. 289 and H.R. 2104, American Cures Act Legislation pertaining to FDA priority review vouchers, generally Legislation pertaining to the applicability of the ACA tax carve out for non-orphan drug designated drugs, generally, including H.R. 3678, Preserving Access to Orphan Drugs Act of 2015 H.R. 3618 and S. 1906, Orphan Drug Fairness Act Issues related to the value of prescription medicines, generally, and including S. 2023, Prescription Drug Affordability Act of 2015 Drug shortage issues Issues related to health care transparency
Client expense: $290,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2016 · first_quarter · Health Issues
National Diabetes Prevention Program; Better care and treatment of people with diabetes under P.L. 111-148 Patient Protection and Affordable Care Act of 2009 (ACA) and P.L. 111-152 The Health Care & Education Affordability Reconciliation Act of 2010: Issues related to diabetes generally, and specifically diabetes screening, medical education and death certificate reporting (Catalyst for Better Diabetes), AHRQ and USPSTF diabetes screening standards; H.R. 1192 and S. 586 National Diabetes Clinical Care Commission Act of 2015; P.L. 114-10, Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) for Special Diabetes Program, CHIP, and childhood obesity; S. 84 and H.R. 3658 Gestational Diabetes Act of 2015; H.R. 1190 and S. 141 Protecting Seniors' Access to Medicare Act of 2015 (IPAB repeal); H.R. 2651 Eliminating Disparities in Diabetes Prevention, Access, and Care Act of 2015 (EDDPAC); cost of diabetes generally; S. 320 and H.R. 744 Medical Innovation Act of 2015; S. 2023 and H.R. 3513 Prescription Drug Affordability Act of 2015; H.R. 3742, Access to Marketplace Insurance Act and general allowance for certain third party payments of cost sharing.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)
2016 · first_quarter · Health Issues
S 318, HR 531 Accelerating Biomedical Research Act HR 744, S 320 Medical Innovation Act (Swear Jar bill) HR 777 Permanent Investment in Health Research Act HR 6 21st Century Cures S 289, HR 2104 American Cures Act HR 2101 Research for All Act S 1077 Advancing Breakthrough Devices for Patients HR 2337 To amend the Federal Food, Drug, and Cosmetic Act to authorize priority review for breakthrough devices HR 160 Protect Medical Innovation Act of 2015 (to repeal the ACA medical device tax) S2014 HR3466 Next Generation Researchers Act HR 3171 HR 3215 HR 3429 S 1917 legislation relating to the regulation of fetal tissue research HR639 Improving Regulatory Transparency for New Medical Therapies Act (signed into law) HR 2820 Stem Cell Therapeutic and Research Reauthorization Act of 2015 (signed into law) HR 2646 S1945 Helping Families in Mental Health Crisis Act of 2015 HR 3731, S 2030 Rare Disease Fund Act of 2015 HR 3729 Limit Fetal Tissue Research S 2141 Transparent Ratings on Usability and Security to Transform Information Technology Act of 2015 or TRUST It Act (with respect to health information technology) S 2624 National Biomedical Research Act S 1878 Advancing Hope Act of 2015 S 2512 Adding Zika Virus to the FDA Priority Review Voucher Program Act S 1101 Medical Electronic Data Technology Enhancement for Consumers' Health Act S 1767 Combination Product Regulatory Fairness Act of 2015 S 1597 Patient-Focused Impact Assessment Act of 2015 S 2055 Medical Countermeasure Innovation Act of 2016 S 1945 Mental Health Reform Act of 2015 S 1622 FDA Device Accountability Act S 849 Advancing Research for Neurological Diseases Act of 2015 S 800 Enhancing the Stature and Visibility of Medical Rehabilitation Research at the NIH Act S 2700 FDA and NIH Workforce Authorities Modernization Act S 2713 Advancing Precision Medicine Act of 2016 S 2745 NIH Strategic Plan and Inclusion in Clinical Research S 2472 Promoting Biomedical Research and Public Health for Patients Act (to reduce regulatory burden on NIH-funded researchers)
Client expense: $36,139 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · first_quarter · Medical/Disease Research/Clinical Labs
S. 320, The Medical Innovation Act. Legislation to authorize the collection of supplemental payments to increase congressional investments in medical research. H.R. 6, 21st Century Cures Act, (multiple provisions including incentives for innovation to help expedite novel treatments and cures, enhancements to FDA capacity and resources, and promotion of precision therapies, potential offsets) Senate Innovations for Healthy Americans Act (text not yet available but likely multiple provisions similar to H.R. 6 including incentives for innovation to help expedite novel treatments and cures, enhancements to FDA capacity and resources, and promotion of precision therapies, potential offsets)
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · first_quarter · Medical/Disease Research/Clinical Labs
H.R. 6, 21st Century Cures Act, (multiple provisions including incentives for innovation to help expedite novel treatments and cures, enhancements to FDA capacity and resources, and promotion of precision therapies, potential offsets) S. 320, The Medical Innovation Act. Legislation to authorize the collection of supplemental payments to increase congressional investments in medical research. Senate Innovations for Healthy Americans Act (text not yet available but likely multiple provisions similar to H.R. 6 including incentives for innovation to help expedite novel treatments and cures, enhancements to FDA capacity and resources, and promotion of precision therapies, potential offsets)
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · first_quarter · Health Issues
Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, FY2017, Medical Center related initiatives H.R.6, 21st Century Cures Act, Medical Center related initiatives Monitor the following: H.R.3291, Medicare Crosswalk Hospital Code Development Act of 2015, generally H.R.3292, Medicare IME Pool Act of 2015, generally H.R.3288, Strengthening DSH and Medicare Through Subsidy Recapture and Payment Reform Act of 2015, generally H.R.4273/S.2409, Medicare and Medicaid Improvements and Adjustments Act of 2015, Medicare reimbursement issues Concussion issues, generally S. 2030, The Advancing Targeted Therapies for Rare Diseases Act of 2015 S. 1622, The FDA Device Accountability Act of 2015 S. 2014, Next Generation Researchers Act S. 800, The Enhancing the Stature and Visibility of Medical Rehabilitation Research at NIH Act S. 849, Advancing Research for Neurological Diseases Act of 2015 S. 2503, Preventing Superbugs and Protecting Patients Act S. 2511, Improving Health Information Technology S. 1878, The Advancing Hope Act of 2015 S. 1077, The Advancing Breakthrough Medical Devices for Patients Act of 2015 S. 1101, The Medical Electronic Data Technology Enhancement for Consumers Health Act S. 2055, The Medical Countermeasures Innovation Act of 2015 S. 1767, The Combination Products Innovation Act of 2015 S. 1597, Patient Focused Impact Assessment Act of 2015 S. 2512, Adding Zika Virus to the FDA Priority Review Voucher Program Act S. 2700, FDA and NIH Workforce Authorities Modernization Act S. 185, Promise for Antibiotics and Therapeutics for Health Act S. 2713, Advancing Precision Medicine Act of 2016 S. 2745, Advancing NIH Strategic Planning and Representation in Medical Research Act S. 2742, Promoting Biomedical Research and Public Health for Patients Act S.2624, National Biomedical Research Act S.320, Medical Innovation Act of 2015
Client expense: Not reported · Firm income: $30,000
Government targets: Defense, Dept of (DOD), HOUSE OF REPRESENTATIVES, SENATE
2016 · first_quarter · Health Issues
Cancer research issues H.R.6, 21st Century Cures Act, Medical research issues Big data issues H.R.4273/S.2409, Medicare and Medicaid Improvements and Adjustments Act of 2015, Medicare reimbursement issues Cancer Moonshot Initiative Precision Medicine S.2624, National Biomedical Research Act S.320, Medical Innovation Act of 2015 S. 2030, The Advancing Targeted Therapies for Rare Diseases Act of 2015 S. 1622, The FDA Device Accountability Act of 2015 S. 2014, Next Generation Researchers Act S. 800, The Enhancing the Stature and Visibility of Medical Rehabilitation Research at NIH Act S. 849, Advancing Research for Neurological Diseases Act of 2015 S. 2503, Preventing Superbugs and Protecting Patients Act S. 2511, Improving Health Information Technology S. 1878, The Advancing Hope Act of 2015 S. 1077, The Advancing Breakthrough Medical Devices for Patients Act of 2015 S. 1101, The Medical Electronic Data Technology Enhancement for Consumers Health Act S. 2055, The Medical Countermeasures Innovation Act of 2015 S. 1767, The Combination Products Innovation Act of 2015 S. 1597, Patient Focused Impact Assessment Act of 2015 S. 2512, Adding Zika Virus to the FDA Priority Review Voucher Program Act S. 2700, FDA and NIH Workforce Authorities Modernization Act S. 185, Promise for Antibiotics and Therapeutics for Health Act S. 2713, Advancing Precision Medicine Act of 2016 S. 2745, Advancing NIH Strategic Planning and Representation in Medical Research Act S. 2742, Promoting Biomedical Research and Public Health for Patients Act
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, Office of the Vice President of the United States, SENATE
2016 · first_quarter · Health Issues
National Diabetes Prevention Program; Better care and treatment of people with diabetes under P.L. 111-148 Patient Protection and Affordable Care Act of 2009 (ACA) and P.L. 111-152 The Health Care & Education Affordability Reconciliation Act of 2010: Issues related to diabetes generally, and specifically diabetes screening, medical education and death certificate reporting (Catalyst for Better Diabetes), AHRQ and USPSTF diabetes screening standards; diabetes issues in Healthy People 2020 and the Office of Disease Prevention and Health Promotion (ODPHP); H.R. 1192 and S. 586 National Diabetes Clinical Care Commission Act of 2015; P.L. 114-10, Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) for Special Diabetes Program, CHIP, and childhood obesity; S. 84 and H.R. 3658 Gestational Diabetes Act of 2015; H.R. 1190 and S. 141 Protecting Seniors' Access to Medicare Act of 2015 (IPAB repeal); H.R. 2651 Eliminating Disparities in Diabetes Prevention, Access, and Care Act of 2015 (EDDPAC); cost of diabetes generally; S. 320 and H.R. 744 Medical Innovation Act of 2015; S. 2023 and H.R. 3513 Prescription Drug Affordability Act of 2015; H.R. 3742, Access to Marketplace Insurance Act and general allowance for certain third party payments of cost sharing; Congressional recognition of World Hemophilia Day
Client expense: $910,000 · Firm income: Not reported
2016 · first_quarter · Pharmacy
S 320 - Medical Innovation Act - NIH funding DEA - change/classification of regulations regarding partial fill of prescriptions Prescription Drug Pricing - no specific bill Direct to Consumer Advertising - no specific bill Negotiating Prescription Drug Prices for Medicare and Medicaid - no specific bill
Client expense: $90,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), SENATE, State, Dept of (DOS)
2016 · first_quarter · Health Issues
PL 114 - 20 - the Medicare Access and Chip Reauthorization Act - response to RFI and proposed quality measurement plan HR 293 - the Protect Continuing Physician Education Act and Patient Care Act - regulations implementing the Sunshine Act HR 6 - 21st Century Cures - provisions impacting Sunshine Act S 320 - Medical Innovation Act - NIH funding Opioid Addiction issues S. 1455 - TREAT ACT, Recovery Enhancement for Addiction Act S. 480 - Reauthorization of NASPER - The National All Schedules Prescription Electronic Reporting Act S. 1392 Safer Prescribing of Controlled Substances Act HR 2805/S. 1134 - Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 DEA - change/classification of regulations regarding partial fill of prescriptions E Prescribing - schedule II drugs S. 524 - Comprehensive Addiction and Recovery Act of 2015 Draft CDC Guideline for Prescribing Opioids for Chronic Pain SAMHSA proposed rules re: confidentiality on alcohol and drug abuse patient records, 42 CFR, Part 2 Prescription Drug Pricing - no specific bill Funding for demonstration projects for access to pain specialists - no specific bill HR 4276/S. 2647 Behavioral Health Coverage Transparency Act HR 4599/S. 2578 - Reducing Unused Medications Act of 2016 - partial fill legislation Access to medically tailored food for low income people - no specific bill Meaningful Use and Electronic Medical Records - HR 3309 - Future Flexibility on HIT Reporting and Advancing Interoperability Act, Expand Meaningful Use Hardship Exceptions HR 2568 - Fair Medical Audits Act of 2015 DEA Reclassification of marijuana to allow scientific research and study - no specific bill Banning Nuclear War - no specific bill S. 2624 - National Biomedical Research Act Gun Violence Research - no specific bill
Client expense: $90,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), SENATE, State, Dept of (DOS)
2015 · fourth_quarter · Health Issues
National Diabetes Prevention Program; Better care and treatment of people with diabetes under P.L. 111-148 Patient Protection and Affordable Care Act of 2009 (ACA) and P.L. 111-152 The Health Care & Education Affordability Reconciliation Act of 2010: Issues related to diabetes generally, and specifically diabetes screening, medical education and death certificate reporting (Catalyst for Better Diabetes), AHRQ and USPSTF diabetes screening standards; diabetes issues in Healthy People 2020 and the Office of Disease Prevention and Health Promotion (ODPHP); H.R. 1074 and S. 539 National Diabetes Clinical Care Commission Act of 2013; P.L. 114-10, Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) for Special Diabetes Program, CHIP, and childhood obesity; S. 84 and H.R. 3658 Gestational Diabetes Act of 2015; H.R. 1190 and S. 141 Protecting Seniors' Access to Medicare Act of 2015 (IPAB repeal); H.R. 2651 Eliminating Disparities in Diabetes Prevention, Access, and Care Act of 2015 (EDDPAC); cost of diabetes generally; S. 320 and H.R. 744 Medical Innovation Act of 2015; S. 2023 and H.R. 3513 Prescription Drug Affordability Act of 2015; H.R. 3742, Access to Marketplace Insurance Act and general allowance for certain third party payments of cost sharing.
Client expense: $620,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Natl Institutes of Health (NIH), SENATE
2015 · fourth_quarter · Health Issues
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 289: American Cures Act - Provisions related to NIH funding S. 320: Medical Innovation Act of 2015 - Provisions related to National Institutes of Health (NIH) funding and covered manufacturer supplemental fees S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to Drug Enforcement Administration (DEA) scheduling S. 483: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the Controlled Substances Act (CSA) S. 683: Compassionate Access, Research Expansion, and Respect States Act of 2015 - Provisions related to regulation of marijuana and impact on legitimate medical research S. 1128: Preserving Access to Orphan Drugs Act - Provisions related to orphan drug tax (113th Congress) S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: The Combination Product Regulatory Fairness Act of 2015 - Provisions related to improvements in the regulation of combination drug-device products S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to importation S. 2055 - the Medical Countermeasure Innovation Act of 2015 H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 471: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the CSA H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to DEA scheduling H.R. 880: American Research and Competitiveness Act of 2015 - Provisions related to the research and development (R&D) tax credit H.R. 909: Andrea Sloan Compassionate Use Reform and Enhancement Act - Provisions related to expanded access H.R. 1321: Microbead-Free Waters Act of 2015 - Provisions related to bills applicability to prescription drugs H.R. 1455: Speeding Access to Already Approved Pharmaceuticals Act of 2015 - Provisions requiring FDA to expedite review of pharmaceuticals that are approved for marketing in the European Union H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 1538: Compassionate Access, Research Expansion, and Respect States Act of 2015 - Provisions related to regulation of marijuana and impact on legitimate medical research H.R. 1576: Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015 - Provisions related to the study of regulatory challenges for the approval of complex generic drugs H.R. 1635: Charlottes Web Medical Access Act of 2015 - Provisions related to regulation of marijuana and impact on legitimate medical research H.R. 2433: To amend the Federal Food, Drug, and Cosmetic Act with respect to enhancing combination products review - Provisions regarding the enhancement of combination products review H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2536: Recovery Enhancement for Addiction Treatment Act - Provisions related to the treatment of drug addiction H.R. 2629: Antibiotic Development to Advance Patient Treatment Act - Provisions related to the approval of certain drugs for use in a limited population of patients H.R. 2805: Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 - Provisions related to the treatment of heroin and prescription opioid abuse H.R. 2820: Stem Cell Therapeutic and Research Reauthorization Act of 2015 - Provisions related to the reauthorization of the National Cord Blood Inventory program and the C.W. Bill Young Cell Transplantation Program H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing H.R. 2872: Opioid Addiction Treatment Modernization Act - Provisions related to the treatment of opioid addiction H.R. 3014: Medical Controlled Substances Transportation Act of 2015 - Provisions related to the transport of controlled substances by physicians in certain situations HR. 3299 - the Strengthening Public Health Emergency Response Act of 2015 H.R. 3537: Synthetic Drug Control Act of 2015 - Provisions related to amending the Controlled Substances Analogue Act and the legislative scheduling of molecules used in legitimate medical research H.R. 3680: Co-Prescribing to Reduce Overdoses Act of 2015 - Provisions related to the prescribing of opioid overdose reversal drug to at-risk patients H.R. 3762, Restoring Americans Healthcare Freedom Reconciliation Act - Provisions related to amending and withdrawing funding from the Affordable Care Act The Regenerative Medicine Regulatory Improvement Act (discussion draft) - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances Breakpoints (discussion draft) - Provisions relating to the updating of breakpoint information for antibiotics on an FDA managed website Drug Supply Chain Security Act issues including the Charitable Donation Exemption Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability; Proposed Rules [CMS-2390-P] Provisions related to 340B program Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Proposed HRSA 340B program mega-guidance - Provisions related to 340B program Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges Physician Payment Sunshine Act implementation issues, such as Open Payments System issues 340B Drug Discount Program policy issues General FDA advocacy Prescription Drug User Fee Act (PDUFA) negotiation and reauthorization Biopharmaceutical and medical innovation policy issues Drug development ecosystem policy issues Drug cost and pricing policy issues Transparency policy issues NIH Funding policy issues Precision Medicine Initiative Biomarker proposed legislation - Draft legislation related to developing a new approval pathway for biomarkers Rogue Internet Pharmacy policy issues Prescription drug abuse policy issues Drug compounding policy issues Nomination of Robert Califf to FDA Commissioner
Client expense: $380,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office
2015 · fourth_quarter · Health Issues
Fertility and multiple sclerosis treatments. H.R. 1735, National Defense Authorization Act for Fiscal Year 2016. S. 1356, National Defense Authorization Act for Fiscal Year 2016. H.R. 744/S. 320, Medical Innovation Act of 2015.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2015 · fourth_quarter · Health Issues
Implementation of Patient Protection & Affordable Health Care Act (P.L. 111-148) and Implementation of Health Care and Education Reconciliation Act (P.L. 111-152) 340B issues and legislative reform proposals Issues related to importation of prescription drugs, including those contained in S. 122, Safe and Affordable Drugs from Canada Act of 2015 Health technology assessment of orphan drugs Sequestration of FDA user fees H.R. 1376, Patient Choice Act of 2015 H.R. 790, Compassionate Freedom of Choice Act of 2015 H.R. 1600, Patients' Access to Treatments Act of 2015 21st Century Cures/Innovation initiatives including H.R. 6, 21st Century Cures Act and the Innovation for Healthier Americans Initiative H.R. 909, Andrea Sloan CURE Act S. 1421 and H.R.971, Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 Implementation of the FDA Safety and Innovation Act (FDASIA) (Pub. L. 112-144) Regulation of innovative biological products for neurodegenerative diseases Issues and policies related to implementation of Orphan Drug Act and orphan drug development S. 320, Medical Innovation Act H.R. 744, Medical Innovation Act H.R. 1130, Chronic Kidney Disease Improvement in Research and Treatment Act of 2015 S. 598, Chronic Kidney Disease Improvement in Research and Treatment Act of 2015 H.R. 1078, Food and Drug Administration Safety Over Sequestration Act of 2015 H.R. 1531 and S.1878, Advancing Hope Act of 2015 Implementation of newborn screening programs Issues and policies related to biosimilars exclusivity period Issues and policies related to biosimilars FDA guidance Issues and policies related to FDA oversight and management Issues and policies related to expanded access programs Issues and policies related to patient involvement with FDA decision making S. 289 and H.R. 2104, American Cures Act Legislation pertaining to FDA priority review vouchers, generally Legislation pertaining to the applicability of the ACA tax carve out for non-orphan drug designated drugs, generally, including H.R. 3678, Preserving Access to Orphan Drugs Act of 2015 H.R. 3618 and S. 1906, Orphan Drug Fairness Act Issues related to the value of prescription medicines, generally, and including S. 2023, Prescription Drug Affordability Act of 2015 Drug shortage issues
Client expense: $260,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2015 · fourth_quarter · Health Issues
HR 6: 21ST CENTURY CURES ACT; PROVISIONS RELATED TO RARE PEDIATRIC DISEASE PRIORITY REVIEW VOUCHER PROGRAM AND PRECISION MEDICINE HR 546: ADVANCING CARE FOR EXCEPTIONAL KIDS(ACE)ACT OF 2015; ALL PROVISIONS OF THE BILL HR 971: ORPHAN PRODUCT EXTENSIONS NOW ACCELERATING CURES AND TREATMENTS ACT OF 2015; PROVISIONS RELATED TO ORPHAN DRUG TAX CREDIT EXCLUSIVITY S 320: MEDICAL INNOVATION ACT OF 2015; PROVISIONS RELATED TO PLATFORM TECHNOLOGIES AND RARE PEDIATRIC DISEASE PRIORITY REVIEW VOUCHER PROGRAM S 1421: ORPHAN PRODUCT EXTENSIONS NOW ACCELERATING CURES AND TREATMENTS ACT OF 2015; PROVISIONS RELATED TO ORPHAN DRUG TAX CREDIT EXCLUSIVITY S 1878: ADVANCING HOPE ACT OF 2015; ALL PROVISIONS OF THE BILL S 2030: ADVANCING TARGETED THERAPIES FOR RARE DISEASES ACT OF 2015; ALL PROVISIONS OF THE BILL
Client expense: $60,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2015 · fourth_quarter · Health Issues
S 318, HR 531 Accelerating Biomedical Research Act HR 744, S 320 Medical Innovation Act (Swear Jar bill) HR 777 Permanent Investment in Health Research Act HR 6 21st Century Cures S 289, HR 2104 American Cures Act HR 2101 Research for All Act S 1077 Advancing Breakthrough Devices for Patients HR 2337 To amend the Federal Food, Drug, and Cosmetic Act to authorize priority review for breakthrough devices HR 160 Protect Medical Innovation Act of 2015 (to repeal the ACA medical device tax) S2014 HR3466 Next Generation Researchers Act HR 3171 HR 3215 HR 3429 S 1917 legislation relating to the regulation of fetal tissue research HR639 Improving Regulatory Transparency for New Medical Therapies Act (signed into law) HR 2820 Stem Cell Therapeutic and Research Reauthorization Act of 2015 (signed into law) HR 2646 S1945 Helping Families in Mental Health Crisis Act of 2015 HR 3731 Rare Disease Fund Act of 2015 (Andrew Los brainchild) HR 3729 Limit Fetal Tissue Research S 2141 Transparent Ratings on Usability and Security to Transform Information Technology Act of 2015 or TRUST It Act (with respect to health information technology)
Client expense: $58,549 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2015 · fourth_quarter · Health Issues
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 289: American Cures Act - Provisions related to National Institutes of Health (NIH) funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to Drug Enforcement Administration (DEA) scheduling S. 483: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the Controlled Substances Act (CSA) S. 683: Compassionate Access, Research Expansion, and Respect States (CARERS) Act of 2015 - Provisions related to regulation of marijuana and impact on legitimate medical research S. 1128: Preserving Access to Orphan Drugs Act - Provisions related to orphan drug tax (113th Congress) S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: Combination Product Regulatory Fairness Act of 2015 - Provisions related to improvements in the regulation of combination drug-device products S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to importation H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 471: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the CSA H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to DEA scheduling H.R. 880: American Research and Competitiveness Act of 2015 - Provisions related to the research and development (R&D) tax credit H.R. 909: Andrea Sloan Compassionate Use Reform and Enhancement Act - Provisions related to expanded access H.R. 1321: Microbead-Free Waters Act of 2015 - Provisions related to bills applicability to prescription drugs H.R. 1455: Speeding Access to Already Approved Pharmaceuticals Act of 2015 - Provisions requiring FDA to expedite review of pharmaceuticals that are approved for marketing in the European Union H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 1538: Compassionate Access, Research Expansion, and Respect States (CARERS) Act of 2015 - Provisions related to regulation of marijuana and impact on legitimate medical research H.R. 1576: Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015 - Provisions related to the study of regulatory challenges for the approval of complex generic drugs H.R. 1635: Charlottes Web Medical Access Act of 2015 - Provisions related to regulation of marijuana and impact on legitimate medical research H.R. 2433: To amend the Federal Food, Drug, and Cosmetic Act with respect to enhancing combination products review - Provisions regarding the enhancement of combination products review H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2536: Recovery Enhancement for Addiction Treatment Act - Provisions related to the treatment of drug addiction H.R. 2629: Antibiotic Development to Advance Patient Treatment Act - Provisions related to the approval of certain drugs for use in a limited population of patients H.R. 2805: Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 - Provisions related to the treatment of heroin and prescription opioid abuse H.R. 2820: Stem Cell Therapeutic and Research Reauthorization Act of 2015 - Provisions related to the reauthorization of the National Cord Blood Inventory program and the C.W. Bill Young Cell Transplantation Program H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing H.R. 2872: Opioid Addiction Treatment Modernization Act - Provisions related to the treatment of opioid addiction H.R. 3014: Medical Controlled Substances Transportation Act of 2015 - Provisions related to the transport of controlled substances by physicians in certain situations H.R. 3537: Synthetic Drug Control Act of 2015 - Provisions related to amending the Controlled Substances Analogue Act and the legislative scheduling of molecules used in legitimate medical research H.R. 3680: Co-Prescribing to Reduce Overdoses Act of 2015 - Provisions related to the prescribing of opioid overdose reversal drug to at-risk patients H.R. 3762, Restoring Americans Healthcare Freedom Reconciliation Act of 2015 - Provisions related to amending and withdrawing funding from the Affordable Care Act The Regenerative Medicine Regulatory Improvement Act (discussion draft) - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances Breakpoints (discussion draft) - Provisions relating to the updating of breakpoint information for antibiotics on an FDA managed website Drug Supply Chain Security Act issues including the Charitable Donation Exemption Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability; Proposed rules [CMS-2390-P] - Provisions related to 340B program Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Proposed HRSA 340B program mega-guidance - Provisions related to 340B program Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges Physician Payment Sunshine Act implementation issues, such as Open Payments System issues 340B Drug Discount Program policy issues General FDA advocacy Prescription Drug User Fee Act (PDUFA) negotiation and reauthorization Biopharmaceutical and medical innovation policy issues Drug development ecosystem policy issues Drug cost and pricing policy issues Transparency policy issues NIH Funding policy issues Precision Medicine Initiative Biomarker proposed legislation - Draft legislation related to developing a new approval pathway for biomarkers Rogue Internet Pharmacy policy issues Prescription drug abuse policy issues Drug compounding policy issues Nomination of Robert Califf to FDA Commissioner
Client expense: $3,820,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)
2015 · fourth_quarter · Medical/Disease Research/Clinical Labs
Presidents Budget, FY 2017 Issue: Funding for Agency for Healthcare Research and Quality (AHRQ), NIH Presidents Budget, FY 2016 H.R. 3020/S. 1695, Labor, HHS, Education and Related Agencies Act, 2016, Title II P.L. 114-113, H.R. 2029, Consolidated Appropriations Act, 2016, Division H, Title II Issues: Support funding for National Institutes of Health (NIH), Agency for Healthcare Research and Quality (AHRQ), biodefense and public health preparedness programs, Maintain NIH salary cap at Executive Level II. Encourage the highest possible allocation for the Labor-HHS Subcommittee. Oppose House proposal to eliminate AHRQ. Oppose rescissions from CMMI and PCORI. President's Budget, FY 2017 H.R. 2029 and draft Senate Military Construction and Veterans Affairs and Related Agencies Appropriations Act, 2016 P.L. 114-113, Consolidated Appropriations Act, 2016, Division J, Title II Issues: Support funding for Veterans Affairs medical research, research infrastructure, and health care. Issue: Support the use of animals in medical research. Issue: Oppose discretionary spending cuts through sequestration, including NIH and other science programs. Issue: Funding for pandemic preparedness and biodefense programs Issue: Draft legislation on protections for human subjects in research S. 289/H.R. 2104, American Cures Act Issue: Increases budget authority for National Institutes of Health NIH), Center for Disease Control and Prevention, Department of Defense Health Program, and the VA Medical and Prosthetics Research Program S. 320/H.R. 744, Medical Innovation Act Issue: Requires covered manufacturers of blockbuster drugs developed, in whole or in part, through federal investments in medical research that enter settlement agreements with a federal agency to pay 1 percent of net income over five years to increase congressional investments in biomedical research. S. 318/H.R. 531, Accelerating Biomedical Research Act Issue: Increases discretionary spending cap to increase funding for the National Institutes of Health (NIH). H.R. 777, Permanent Investment in Health Research Act Issue: Creates mandatory appropriation for the National Institutes of Health (NIH), adjusted annually for inflation. H.R. 6, 21st Century Cures Act Senate HELP Committee Innovation Initiative Issue: Support increased funding for medical research, reduce administrative and regulatory burden on scientists and research institutions, and support young investigators. H.R. 2102, Research for All Act of 2015 Issue: Support inclusion of male and female cells and animals in basic research, and NIH updating its guidelines on inclusion of women in clinical research. Issue: FDA regulation of Laboratory Developed Tests (LDTs) Issue: Support federal funding for research using human fetal tissue. H.R. 3466/S. 2014, Next Generation Research Act Issue: Support National Institutes of Health programs for new and young scientists. H.R. 3119, draft Senate legislation, Palliative Care and Hospice Education and Training Act Issue: Health professions education on palliative care Submitted comments to: -HRSA on Proposed Omnibus Guidance on 340B Drug Pricing Program -FDA on International Scheduling of Ketamine -NIH on its strategic plan to advance research on the health and well-being of sexual and gender minorities
Client expense: $780,000 · Firm income: Not reported
Government targets: Agency for Healthcare Research & Quality (AHRQ), Agriculture, Dept of (USDA), Bureau of the Census, Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Drug Enforcement Administration (DEA), Federal Reserve System, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Interior, Dept of (DOI), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), Veterans Affairs, Dept of (VA), White House Office
2015 · fourth_quarter · Science/Technology
Presidents Budget, FY 2017 Issue: Funding for Agency for Healthcare Research and Quality (AHRQ), NIH Presidents Budget, FY 2016 H.R. 3020/S. 1695, Labor, HHS, Education and Related Agencies Act, 2016, Title II P.L. 114-113, H.R. 2029, Consolidated Appropriations Act, 2016, Division H, Title II Issues: Support funding for National Institutes of Health (NIH), Agency for Healthcare Research and Quality (AHRQ), biodefense and public health preparedness programs. Maintain NIH salary cap at Executive Level II. Encourage the highest possible allocation for the Labor-HHS Subcommittee. Oppose House proposal to eliminate AHRQ. Oppose rescissions from CMMI and PCORI. President's Budget, FY 2017 H.R. 2029 and draft Senate Military Construction and Veterans Affairs and Related Agencies Appropriations Act, 2016 P.L. 114-113, Consolidated Appropriations Act, 2016, Division J, Title II Issues: Support funding for Veterans Affairs medical research, research infrastructure, and health care. Issue: Oppose discretionary spending cuts through sequestration, including NIH and other science programs. Issue: Supporting the use of animals in medical research. Issue: Funding for pandemic preparedness and biodefense programs. Issue: Draft legislation on protections for human subjects in research. S. 289/H.R. 2104, American Cures Act Issue: Increases budget authority for National Institutes of Health (NIH), Center for Disease Control and Prevention, Department of Defense Health Program, and the VA Medical and Prosthetics Research Program S. 320/H.R. 744, Medical Innovation Act Issue: Requires covered manufacturers of blockbuster drugs developed, in whole or in part, through federal investments in medical research that enter settlement agreements with a federal agency to pay 1 percent of net income over five years to increase congressional investments in biomedical research. S. 318/H.R. 531, Accelerating Biomedical Research Act Issue: Increases discretionary spending cap to increase funding for the National Institutes of Health (NIH). H.R. 777, Permanent Investment in Health Research Act Issue: Creates mandatory appropriation for the National Institutes of Health (NIH), adjusted annually for inflation. H.R. 6, 21st Century Cures Act Senate HELP Committee Innovation Initiative Issue: Support increased funding for medical research, reduce administrative and regulatory burden on scientists and research institutions, and support young investigators. H.R. 2102, Research for All Act of 2015 Issue: Support inclusion of male and female cells and animals in basic research, and NIH updating its guidelines on inclusion of women in clinical research. Issue: FDA regulation of Laboratory Developed Tests (LDTs) H.R. 3466/S. 2014, Next Generation Research Act Issue: Support National Institutes of Health programs for new and young scientists. H.R. 1806, The America COMPETES Act of 2015 Issue: Support increased funding for the National Science Foundation (NSF) Issue: Support federal funding for research using human fetal tissue. Submitted comments to: -FDA on International Scheduling of Ketamine -NIH on strategies to enhance diversity in the physician�scientist workforce -NIH on its strategic plan to advance research on the health and well-being of sexual and gender minorities
Client expense: $780,000 · Firm income: Not reported
Government targets: Agency for Healthcare Research & Quality (AHRQ), Agriculture, Dept of (USDA), Bureau of the Census, Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Drug Enforcement Administration (DEA), Federal Reserve System, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Interior, Dept of (DOI), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), Veterans Affairs, Dept of (VA), White House Office
2015 · fourth_quarter · Health Issues
Presidents Budget, FY 2017 Issue: Funding for Agency for Healthcare Research and Quality (AHRQ), Hospital Preparedness Program, NIH, Title VII & VIII Presidents Budget, FY 2016 H.R. 3020/S. 1695, Labor, HHS, Education and Related Agencies Act, 2016, Title II P.L. 114-113, H.R. 2029, Consolidated Appropriations Act, 2016, Division H, Title II Issues: Support funding for National Institutes of Health (NIH), Title VII and Title VIII health professions and nursing education programs, Agency for Healthcare Research and Quality (AHRQ), National Health Service Corps (NHSC), Childrens Hospitals Graduate Medical Education (CHGME), Health Resources and Services Administration (HRSA), the Prevention and Public Health Fund (PPHF), biodefense and public health preparedness programs,. Maintain NIH salary cap at Executive Level II. Encourage the highest possible allocation for the Labor-HHS Subcommittee. Oppose House proposal to eliminate AHRQ. Oppose rescissions from CMMI and PCORI. President's Budget, FY 2017 H.R. 2029 and draft Senate Military Construction and Veterans Affairs and Related Agencies Appropriations Act, 2016 P.L. 114-113, Consolidated Appropriations Act, 2016, Division J, Title II Issues: Support funding for Veterans Affairs medical research, research infrastructure, and health care. Issue: Support mandatory funding for Community Health Centers and the National Health Service Corps (NHSC) authorized under P.L. 111-148, the Patient Protection and Affordable Care Act, Title V and Section 10503. Draft Debt in Health Education Loan Programs (DebtHELP) legislative proposal Issues: Expand National Health Service Corps State Loan Repayment program, and align Department of Education and HRSA student loan programs. H.R. 2124/S. 1148, Resident Physician Shortage Reduction Act of 2015 Issues: Support lifting cap on number of residents Medicare will count when determining teaching hospitals' Medicare Direct Graduate Medical Education (DGME) and Indirect Medical Education (IME) payments Issues: Support lifting cap on number of residents Medicare will count when determining teaching hospitals' Medicare Direct Graduate Medical Education (DGME) and Indirect Medical Education (IME) payments and increase Graduate Medical Education (GME) accountability and transparency. Issue: Funding and reporting requirements for Teaching Health Center Graduate Medical Education program under section 340G of the Public Health Service Act. H.R. 3288, Strengthening DSH and Medicare through Subsidy Recapture and Payment Reform Act of 2015 Issue: Alter DSH payment methodology and increase DSH spending in non-Medicaid expansion states H.R. 3292, Medicare IME Pool Act of 2015 Issue: Oppose redesign of Medicare Indirect Medical Education financing and redistribution. H.R. 3291, Medicare Crosswalk Hospital Code Development Act of 2015 Issue: Create a crosswalk between Medicare Part A and Part B payments P.L. 114-10, Medicare Access and CHIP Reauthorization Act of 2015. Issues: Support repeal of Medicare's sustainable growth rate (SGR) formula; Medicare physician payment reform; extension of the Childrens Health Insurance Program (CHIP); and extension of mandatory funding for the National Health Service Corps (NHSC). Issue: Support the use of animals in medical research. Issue: Promote interprofessional education and training of the health care workforce. Issue: Support funding for the National Healthcare Workforce Commission. Issue: Oppose reduction in Medicare hospital outpatient department reimbursement. P.L. 114-74, H.R. 1314, Bipartisan Budget Act of 2015 Issue: Oppose Medicare site-neutral payment policy. Oppose extension of Medicare sequester S. 2107/H.R. 1006, Building A Health Care Workforce for the Future Act Issue: Support bill to increase scholarship opportunities for medical students and encourage primary care workforce development. Issue: Oppose inclusion of Medicare add-on payments in Hospital-Acquired Condition (HAC) program. Issue: Support delay of enforcement of new CMS inpatient criteria (e.g., "Two-Midnight" rule) in FY 2016 Inpatient Prospective Payment System (IPPS) final rule. Issue: Support Medicare GME per Resident Amount and cap trigger technical corrections and administrative relief. H.R. 1343, Establishing Beneficiary Equity in the Hospital Readmissions Program Act of 2015. S. 688, Hospital Readmission Accuracy and Accountability Act. Issue: Support inclusion of socioeconomic status as part of hospital readmissions program, including support for adoption of National Quality Forum (NQF) recommendations. President's Budget, FY 2016 Issues: Oppose proposed reductions in Medicare Direct Graduate Medical Education (DGME) and Indirect Medical Education (IME) payments; oppose use of Medicare GME funding for creation of new GME grant program; oppose elimination of Children's Hospitals GME program. Issue: Legislation on educating health professionals regarding appropriate use of antibiotics, prescription drug abuse, pain management, female genital mutilation, and sepsis. Issue: Implementation of the 340B drug pricing program. Oppose efforts to restrict the program. Issue: Oppose Medicare payment reductions as offsets for non-Medicare spending. Issue: Oppose extension of Medicare sequester Issue: Oppose Medicare hospital cuts as offsets for physician payment reform. Issue: Preserve funding for the Primary Care Residency Expansion program. P.L. 114-41, Surface Transportation and Veterans Health Care Choice Improvement Act of 2015 Issue: Support improved contracting with academic affiliates and increased VA GME funding. H.R.1272, Doctors Helping Heroes Act of 2015 Issue: Support expansion of the Conrad 30 J-1 visa waiver program and physician immigration to address VA workforce shortages S. 289/H.R. 2104, American Cures Act Issue: Increases budget authority for National Institutes of Health NIH), Center for Disease Control and Prevention, Department of Defense Health Program, and the VA Medical and Prosthetics Research Program S. 320/H.R. 744, Medical Innovation Act Issue: Requires covered manufacturers of blockbuster drugs developed, in whole or in part, through federal investments in medical research that enter settlement agreements with a federal agency to pay 1 percent of net income over five years to increase congressional investments in biomedical research. S. 318/H.R. 531, Accelerating Biomedical Research Act Issue: Increases discretionary spending cap to increase funding for the National Institutes of Health (NIH). H.R. 777, Permanent Investment in Health Research Act Issue: Creates mandatory appropriation for the National Institutes of Health (NIH), adjusted annually for inflation. H.R. 6, 21st Century Cures Act Senate HELP Committee Innovation Initiative Issue: Support increased funding for medical research, reduce administrative and regulatory burden on scientists and research institutions, and support young investigators. H.R. 2102, Research for All Act of 2015 Issue: Support inclusion of male and female cells and animals in basic research, and NIH updating its guidelines on inclusion of women in clinical research. Issue: FDA regulation of Laboratory Developed Tests (LDTs) Draft Community Based Medical Education Act of 2014 Issue: Oppose reduction of Medicare GME/IME payments S. 1455, Recovery Enhancement for Addiction Treatment (TREAT) Act Issue: Support legislation to increase access to care for patients addicted to opioids Draft Hospital Improvements for Payment (HIP) Act of 2014 Issues: Support repeal of CMS Two-Midnights Rule, extending RAC audit moratorium for short stays, and permanent bundle program. Issue: Oppose further delays in the implementation of the ICD-10 system H.R. 1411, Expanding Nutrition's Role in Curricula and Healthcare Act (ENRICH Act) Issue: Support grants for medical schools to develop or expand nutrition and physical activity curricula. Issue: Funding for Ebola Treatment Centers and hospital preparedness Issue: Educate congressional staff on academic medicines missions, including education, research, patient care, GME, workforce, and physician shortages in rural and urban communities. H.R. 2513, Promoting Access, Competition, and Equity Act of 2015 Issue: Oppose easing restrictions on physician owned hospitals Issue: Senate Finance Committee Chronic Care Workgroup, support and send comments on efforts to improve care for Medicare patients with chronic conditions. H.R. 3285, Reducing Disparities Using Care Models and Education Act of 2015 Issue: Studying and developing guidelines to reduce health disparities Draft Health Equity and Accountability Act Issue: Addressing health equity through health care workforce programs Issue: Support federal funding for research using human fetal tissue. H.R. 3119, draft Senate legislation, Palliative Care and Hospice Education and Training Act Issue: Health professions education on palliative care Submitted comments to: -HRSA on Proposed Omnibus Guidance on 340B Drug Pricing Program -FDA on International Scheduling of Ketamine -CMS on implementation of the Medicare Access and CHIP Reauthorization Act of 2015 -NIH on its strategic plan to advance research on the health and well-being of sexual and gender minorities -HHS on nondiscrimination in heath programs and activities
Client expense: $780,000 · Firm income: Not reported
Government targets: Agency for Healthcare Research & Quality (AHRQ), Agriculture, Dept of (USDA), Bureau of the Census, Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Drug Enforcement Administration (DEA), Federal Reserve System, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Interior, Dept of (DOI), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), Veterans Affairs, Dept of (VA), White House Office