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FDA and NIH Workforce Authorities Modernization Act
Legislative Progress
Momentum (last 30 days)
0
score
0 actions · 0 new cosponsors · 0 votes
Speed vs cohort
82pct
32d open
vs 3,548 other S bills in the 114th — cohort avg 43d
FDA and NIH Workforce Authorities Modernization Act (Sec. 2) This bill amends the Public Health Service Act to revise the Silvio O. Conte Senior Biomedical Research Service to: (1) increase the limit on the number of members, (2) expand eligibility for appointment, (3) set a maximum pay rate, and (4) remove the option for members to contribute to the retirement system of an institution of higher education. The Government Accountability Office (GAO) must report on these amendments. (Sec. 3) This bill amends the Federal Food, Drug, and Cosmetic Act to grant the Food and Drug Administration (FDA) additional hiring authority for scientific, technical, or professional positions that support the development, review, and regulation of medical products. The FDA must report on its need for qualified individuals for such positions and must include a recruitment and retention plan. The GAO must report on the FDA’s ability to hire, train, and retain qualified staff. (Sec. 4) The FDA must establish one or more Intercenter Institutes. Each institute must coordinate activities applicable to a major disease area among the FDA centers that review products. Activities may include coordinating staff with relevant expertise, streamlining product review, and enhancing interactions with patients, sponsors, and the biomedical community. (Sec. 5) Scientific meetings directly related to the duties of a Department of Health and Human Services (HHS) professional must not be considered conferences for purposes of certain reporting requirements and restrictions on conference travel. Each division of HHS must report on scientific meeting attendance and related travel spending. (Sec. 6) The bill revises Board of Directors membership, Executive Director compensation, and accounting for the Reagan-Udall Foundation for the FDA. (Sec. 7) The Paperwork Reduction Act does not apply to National Institutes of Health research. (Sec. 9) For certain indications, the FDA may rely upon a summary of clinical data to approve a supplemental application for a drug. (Sec. 10) The bill revises provisions regarding: (1) FDA screening of the Adverse Event Reporting System, and (2) evaluation of elements to assure safe use of drugs. The FDA must publish: (1) best practices for using the Adverse Event Reporting System, (2) criteria for publishing adverse event information, and (3) best practices for drug safety surveillance activities for newly approved medications. The FDA no longer must prepare a summary analysis of adverse drug reaction reports for recently approved drugs. (Sec. 11) Biological products are not subject to provisions that refer to an official compendium of drug information. (Sec. 12) The manufacturer or distributor of an investigational drug for a serious condition must publish a policy for compassionate use of the drug. (Sec. 13) HHS must finalize the guidance entitled “Expanded Access to Investigational Drugs for Treatment Use--Qs & As.” The guidance must explain how HHS uses adverse drug event data from compassionate use. (Sec. 14) This bill amends the Orphan Drug Act to authorize HHS to defray all the costs of development of orphan drugs (drugs for rare conditions), instead of only certain testing expenses. (Sec. 15) HHS must facilitate the development of standards to support development and review of regenerative medicine and advanced therapies. (Sec. 16) FDA guidance must include specified information, including the statutory provisions or regulations that are the basis for policy decisions. (Sec. 17) The Paperwork Reduction Act does not apply to voluntary collection of information during a public health emergency or while determining whether there is a public health emergency. (Sec. 18) The bill revises provisions regarding: movement of impounded drugs, pediatric study plans, reporting on drug shortages, reporting on inspections of establishments manufacturing drugs or medical devices, requests to classify medical devices, priority review of qualified infectious disease products, use of clinical investigation data from outside the United States, and medical gasses. The bill makes technical changes to various provisions regarding medical products.
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Filing registrants (33)
Placed on Senate Legislative Calendar under General Orders. Calendar No. 427.
Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander with an amendment in the nature of a substitute. Without written report.
Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Introduced in Senate
Bills with similar content found using semantic analysis.
Sources: Congress.gov
2016 · fourth_quarter · Health Issues
Pharmaceutical innovation, precision medicine, rare diseases, platform technologies, Innovation For Healthier Americans H.R. 6 - 21st Century Cures S. 2030 - Advancing Targeted Therapies for Rare Diseases Act of 2015 S. 2700 - FDA and NIH Workforce Authorities Modernization Act S. 2713 - Advancing Precision Medicine Act of 2016 S. 2742 - Promoting Biomedical Research and Public Health for Patients Act S. 1878 - Advancing Hope Act S. 1597 - Patient Focused Impact Assessment Act S. 2912 - Right to Try Act
Client expense: $80,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Pharmacy
Reimbursement of Pharmacist Services - HR592/S314 Transitions of Care Track and Trace/Supply Chain Health Information Technology Immunizations Compounding Tele-Medicine Quality Rating AMP FULs/MAC Pricing Biosimiliars/Biologic Products (S 2700) Drug Importation Generics Labeling Pharmacy Benefit Managers Preferred Pharmacy Network (HR793) Electronic Labeling 21st Century Cures/Innovation Bills (HR6, HR34) Drug Disposal/Management Drug Prices Direct and Indirect Remuneration Fees (HR 5951, S3308) Lab Developed Tests
Client expense: $30,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Office of Natl Drug Control Policy (NDCP), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA)
2016 · fourth_quarter · Health Issues
Provisions of PL 111-148 and PL 111-152 impacting Medicare Part D such as formulary requirements, PBM disclosure provisions, implementation of the prescriber registration rules and definition of negotiated price. Regulatory design and coverage of pharmacy benefits in health reform exchanges and the commercial market (essential health benefits, grandfathering, e-prescribing, PBM disclosure requirements, specialty pharmacy, mail-service pharmacy, formulary transparency, and medical loss ratio). Regulatory and proposed legislative changes to Medicare part D including non-interference, pharmacy networks, classes of clinical concern, mail-service pharmacy, EGWP waivers, MTM expansion, long term care pharmacy, recovery audit contractors. Implementation of changes to the definition of Average Manufacturer Price in Medicaid Issues related to the management of Medicaid prescription drug benefits Legislation to promote generic drugs. Issues related to prescription drug abuse in Medicare. H.R.2: Medicare Access and CHIP Reauthorization Act of 2015 - provisions related to the expansion of availability of Medicare data H.R.244: The MAC Transparency Act H.R.793/S1190: The Ensuring Seniors Access to Local Pharmacies Act H.R.1021: The Protecting the Integrity of Medicare Act H.R.1600: The Patient Access to Treatments Act Provisions related to the 21st Century Cures Initiative (Energy and Commerce) and Innovations for Healthier Americans (HELP Committee). Issues related to the affordability of prescription drugs and competitive marketplace, including: pedigree, FDA user fees, manufacturer market and data exclusivity, REMS, biosimilars. H.R.804: The Access to Medicare Data Act H.R.2298: The Medicare Drug Abuse Prevention Act H.R.6: 21st Century Cures Act S.2700: The FDA and NIH Workforce Authorization Modernization Act - Provisions related to biologic drugs H.R.2841: The FAST Generics Act S.3056: The Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2016 H.R. 4784/S.2651: The Increasing Competition in Pharmaceuticals Act H.R. 5573/S.3094 The Price Relief, Innovation, and Competition for Essential Drugs Act or the PRICED Act
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
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
Client expense: $755,506 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), General Services Administration (GSA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), SENATE
Client expense: $260,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
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)
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
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)
2016 · fourth_quarter · Medicare/Medicaid
Monitor federal issues and legislation related to healthcare policy. Monitor federal issues and legislation related to Medicare reimbursement. Monitor implementation of Medicare Access and CHIP Reauthorization Act of 2015 (P.L. 114-10). Monitor implementation of the Patient Protection and Affordable Care Act (P.L. 111-148). Extend Section 3111, P.L. 111-148. Monitor the implementation of Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act, 2017, and Zika Response and Preparedness Act (P.L. 114-223). H.R. 6, House 21st Century Cures Act. H.R. 270, Flexibility in Health IT Reporting (Flex-IT) Act of 2015. H.R.775, Medicare Access to Rehabilitation Services Act of 2015. H.R. 1600, Patients' Access to Treatments Act of 2015. H.R. 1725, National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015. H.R. 1859, Ensuring Children's Access to Specialty Care Act of 2015. H.R. 2256, Veterans Information Modernization Act. H.R. 2464, Demanding Accountability for Veterans Act of 2015. H.R. 3020, House Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2015. H.R. 3309, Flex-IT 2 Act H.R. 4227, Medicare Advantage Bill of Rights. H.R. 4848, HIP Act H.R. 4909, National Defense Authorization Act for Fiscal Year 2017 H.R. 5001, Flexibility in Electronic Health Record Reporting Act. H.R. 5122, To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models. H.R. 5293, Department of Defense Appropriations, FY 2017. H.R.5721, Local Coverage Determination Clarification Act S. 480, National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015. S.539, Medicare Access to Rehabilitation Services Act of 2015. S. 2392, Medicare Advantage Bill of Rights. S. 2511, Improving Health Information Technology Act. S. 2822, Flexibility in Electronic Health Record Reporting Act S. 2943, National Defense Authorization Act for Fiscal Year 2017 S. 2978, The Protect Continuing Physician Education and Patient Care Act. S. 3000, Department of Defense Appropriations, FY 2017. S. 3040, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations, FY 2017. S.3173, EHR Regulatory Relief Act. Senate 21st Century Cures Act counterpart package, including S. 2700, S.185, S.2713, S.2745, S.2742, S.1878, S.1077, S.1101, S.2055, S.1767, S.1597, S.2512, S.2030, S.1622, S.2014, S.800, S.849, S.2503, and S.2511. Funding for NIH, CDC, DOD, related to arthritis and rheumatic disease research and education. Funding for Pediatric Subspecialty Loan Repayment Program. Draft, House Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations, FY 2017.
Client expense: $110,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Budget/Appropriations
Monitor federal issues and legislation related to healthcare policy. Monitor federal issues and legislation related to Medicare reimbursement. Monitor implementation of Medicare Access and CHIP Reauthorization Act of 2015 (P.L. 114-10). Monitor implementation of the Patient Protection and Affordable Care Act (P.L. 111-148). Extend Section 3111, P.L. 111-148. Monitor the implementation of Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act, 2017, and Zika Response and Preparedness Act (P.L. 114-223). H.R. 6, House 21st Century Cures Act. H.R. 270, Flexibility in Health IT Reporting (Flex-IT) Act of 2015. H.R.775, Medicare Access to Rehabilitation Services Act of 2015. H.R. 1600, Patients' Access to Treatments Act of 2015. H.R. 1725, National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015. H.R. 1859, Ensuring Children's Access to Specialty Care Act of 2015. H.R. 2256, Veterans Information Modernization Act. H.R. 2464, Demanding Accountability for Veterans Act of 2015. H.R. 3020, House Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2015. H.R. 3309, Flex-IT 2 Act H.R. 4227, Medicare Advantage Bill of Rights. H.R. 4848, HIP Act H.R. 4909, National Defense Authorization Act for Fiscal Year 2017 H.R. 5001, Flexibility in Electronic Health Record Reporting Act. H.R. 5122, To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models. H.R. 5293, Department of Defense Appropriations, FY 2017. H.R.5721, Local Coverage Determination Clarification Act S. 480, National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015. S.539, Medicare Access to Rehabilitation Services Act of 2015. S. 2392, Medicare Advantage Bill of Rights. S. 2511, Improving Health Information Technology Act. S. 2822, Flexibility in Electronic Health Record Reporting Act S. 2943, National Defense Authorization Act for Fiscal Year 2017 S. 2978, The Protect Continuing Physician Education and Patient Care Act. S. 3000, Department of Defense Appropriations, FY 2017. S. 3040, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations, FY 2017. S.3173, EHR Regulatory Relief Act. Senate 21st Century Cures Act counterpart package, including S. 2700, S.185, S.2713, S.2745, S.2742, S.1878, S.1077, S.1101, S.2055, S.1767, S.1597, S.2512, S.2030, S.1622, S.2014, S.800, S.849, S.2503, and S.2511. Funding for NIH, CDC, DOD, related to arthritis and rheumatic disease research and education. Funding for Pediatric Subspecialty Loan Repayment Program. Draft, House Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations, FY 2017.
Client expense: $110,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Health Issues
Monitor federal issues and legislation related to healthcare policy. Monitor federal issues and legislation related to Medicare reimbursement. Monitor implementation of Medicare Access and CHIP Reauthorization Act of 2015 (P.L. 114-10). Monitor implementation of the Patient Protection and Affordable Care Act (P.L. 111-148). Extend Section 3111, P.L. 111-148. Monitor the implementation of Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act, 2017, and Zika Response and Preparedness Act (P.L. 114-223). H.R. 6, House 21st Century Cures Act. H.R. 270, Flexibility in Health IT Reporting (Flex-IT) Act of 2015. H.R.775, Medicare Access to Rehabilitation Services Act of 2015. H.R. 1600, Patients' Access to Treatments Act of 2015. H.R. 1725, National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015. H.R. 1859, Ensuring Children's Access to Specialty Care Act of 2015. H.R. 2256, Veterans Information Modernization Act. H.R. 2464, Demanding Accountability for Veterans Act of 2015. H.R. 3020, House Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2015. H.R. 3309, Flex-IT 2 Act H.R. 4227, Medicare Advantage Bill of Rights. H.R. 4848, HIP Act H.R. 4909, National Defense Authorization Act for Fiscal Year 2017 H.R. 5001, Flexibility in Electronic Health Record Reporting Act. H.R. 5122, To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models. H.R. 5293, Department of Defense Appropriations, FY 2017. H.R.5721, Local Coverage Determination Clarification Act S. 480, National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015. S.539, Medicare Access to Rehabilitation Services Act of 2015. S. 2392, Medicare Advantage Bill of Rights. S. 2511, Improving Health Information Technology Act. S. 2822, Flexibility in Electronic Health Record Reporting Act S. 2943, National Defense Authorization Act for Fiscal Year 2017 S. 2978, The Protect Continuing Physician Education and Patient Care Act. S. 3000, Department of Defense Appropriations, FY 2017. S. 3040, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations, FY 2017. S.3173, EHR Regulatory Relief Act. Senate 21st Century Cures Act counterpart package, including S. 2700, S.185, S.2713, S.2745, S.2742, S.1878, S.1077, S.1101, S.2055, S.1767, S.1597, S.2512, S.2030, S.1622, S.2014, S.800, S.849, S.2503, and S.2511. Funding for NIH, CDC, DOD, related to arthritis and rheumatic disease research and education. Funding for Pediatric Subspecialty Loan Repayment Program. Draft, House Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations, FY 2017.
Client expense: $110,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Health Issues
H.R. 6, 21st Century Cures Act (Upton) - new cures and treatments H.R. 34, 21st Century Cures Act (Upton) - medical innovation, mental health, health information technology, telehealth, opioid funding, privacy H.R. 636, Federal Aviation Administration Reauthorization Act (Tiberi) - air ambulance amendments H.R. 691, Telehealth Modernization Act (Matsui-Johnson) - telemedicine H.R. 1189, Preserving Employee Wellness Programs Act (Kline) - employee wellness programs H.R. 2300, Empowering Patients First Act (Price) - health reform issues H.R. 2646, Helping Families in Mental Health Crisis Act (Murphy) - compliance with parity requirements, mental health services H.R. 2712, Commonsense Reporting and Verification Act (Black) - employer reporting and eligibility verification for ACA subsidies H.R. 2745, Standard Merger and Acquisition Reviews Through Equal Rules Act (Farenthold) - FTC-DOJ rules for reviewing mergers H.R. 3099, RAISE Family Caregivers Act (Harper) - national strategy to support family caregivers H.R. 3463, Aligning Childrens Dental Coverage Act (Griffith-DeGette) - rules for stand-alone dental plans H.R. 4276, Behavioral Health Coverage Transparency Act (Kennedy) - disclosure requirements relating to mental health parity H.R. 4641, Best Practices for Pain Management (Brooks) - HHS Task Force to review, revise, and disseminate best practices for pain management H.R. 4771, HEALTH Act (Franks) - medical liability reforms H.R. 5284, World's Greatest Healthcare Plan Act (Sessions) - health reform issues Patient Choice, Affordability, Responsibility, and Empowerment Act (Burr-Hatch-Upton) - health reform issues S. 185, Promise for Antibiotics and Therapeutics for Health Act (Hatch) - FDA drug approval process S. 466, Quality Care for Moms and Babies Act (Stabenow) - pediatric quality measures S. 620, Preserving Employee Wellness Programs Act (Alexander) - employee wellness programs S. 961, Data Security Act (Carper) - data security S. 1077, Advancing Breakthrough Devices for Patients Act (Burr) - priority review of breakthrough medical devices S. 1427, Quality Measure Alignment Act (Stabenow) - facilitating coordination and alignment between public and private sectors on quality and efficiency measures S. 1719, RAISE Family Caregivers Act (Collins) - national strategy to support family caregivers S. 1996, Commonsense Reporting Act (Warner) - employer reporting and eligibility verification for ACA subsidies S. 2141, TRUST IT Act, (Cassidy) - health IT rating system S. 2646, Veterans Choice Improvement Act (Burr) - veterans health care S. 2680, Mental Health Reform Act (Alexander) - compliance with parity requirements, mental health services S. 2700, FDA and NIH Workforce Authorities Modernization Act (Alexander) - medical innovation amendments S. 2985, World's Greatest Healthcare Plan Act (Cassidy) - health reform issues S. 3244, Aligning Children's Dental Coverage Act (Roberts-Bennett) - rules for stand-alone dental plans Regulatory Issues: HIPAA administrative simplification issues, including standards for privacy, security, and electronic transactions and code sets (including ICD-10), identifiers including the health plan identifier, enforcement; cybersecurity; FEHBP enrollment data clearinghouse initiative, the enrollment reconciliation process, and a related OPM reimbursement factor for records that cannot be reconciled; issues relating to health insurance plan participation in FEHBP, including contract requirements; issues relating to similarly sized subscriber group (SSSG) and MLR requirements under the FEHBP; implementation of the health savings account provisions of the Medicare Act; issues related to Medicare Secondary Payer requirements; issues related to implementation of the National Health Information Infrastructure; electronic health records, personal health records, and similar technologies; issues relating to market consolidation; issues related to hospital consolidation; issues relating to quality improvement; issues related to potential priority research topics for the effective health care program; issues relating to the national health data stewardship; issues relating to hospital outpatient measurement and reporting; prescription drug pricing; issues relating to "meaningful use" requirements for health information technology; issues related to the collection of race and ethnicity data; issues related to medical loss ratios; reference pricing; review of rates for reasonableness; preexisting condition insurance plans; issues relating to antitrust; accountable care organizations; provider non-discrimination; coverage of preventive services; contraceptive coverage; pre-existing condition exclusions; lifetime and annual dollar limits on benefits; patient protections; grandfathered health plan provisions; issues relating to the annual fee on health insurance providers; health plan automatic enrollment requirements; issues related to qualified health plans including certification and rate filing templates; health insurance market rules; reinsurance, risk corridors, and risk adjustment (commonly referred to as the 3 Rs); dependent coverage; summary of benefits and coverage disclosures; benefit and payment parameters; essential health benefits, actuarial value, and accreditation; issues related to fraud, waste, abuse, Stark/Anti-Kickback laws and regulations; issues related to supplemental products; issues related to HIPAA excepted benefits; issues related to the federally-facilitated marketplaces (i.e., Exchanges/formerly referred to as the web portal); issues related to business continuity in relation to pandemics or natural events (e.g., hurricane, tornado, etc.); issues related to small employer group size; issues related to Certificate of Public Advantage; and other issues relating to health care reform implementation.
Client expense: $1,330,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Office of Personnel Management (OPM), SENATE, Treasury, Dept of, White House Office
2016 · fourth_quarter · Health Issues
H.R. 1427/S. 804 - Medicare CGM Access Act of 2015 H.R. 6 - 21st Century Cures Act S. 2700 - FDA and NIH Workforce Authorities Modernization Act H.R. 1192/S. 586 - National Diabetes Clinical Care Commission Act
Client expense: $110,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Health Issues
no specific bills: Innovation, Duchenne Muscular Dystrophy, platform technologies Innovation For Healthier Americans H.R. 6 - 21st Century Cures S. 2030 - Advancing Targeted Therapies for Rare Diseases Act of 2015 S. 2700 - FDA and NIH Workforce Authorities Modernization Act S. 2713 - Advancing Precision Medicine Act of 2016 S. 2742 - Promoting Biomedical Research and Public Health for Patients Act S. 1878 - Advancing Hope Act S. 1597 - Patient Focused Impact Assessment Act S. 2912 - Right to Try Act H.R. 34 - 21st Century Cures Act
Client expense: Not reported · Firm income: $80,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Health Issues
Health care reform, drug importation, 340b, biosimilars PL 111-148 - The Patient Protection and Affordable Care Act, PL 111-152 - The Reconciliation Act of 2010, implementation PL 112-144 - The Food and Drug Administration Safety and Innovation Act, implementation H.R. 6 - 21st Century Cures Innovation For Healthier Americans S. 2700 - FDA and NIH Workforce Authorities Modernization Act S. 1878 - Advancing Hope Act S. 2912 - Right to Try Act ***no specific bills, importation, Prescription Drug User Fee Act Renewal and associated policies, supply chain integrity, user fee sequester, Innovation
Client expense: Not reported · Firm income: $60,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2016 · fourth_quarter · Health Issues
PL 111-148 - The Patient Protection and Affordable Care Act, implementation PL 112-144 - The Food and Drug Administration Safety and Innovation Act, implementation H.R. 3204 - The Drug Quality and Security Act, implementation H.R. 6 - 21st Century Cures H.R. 3762 - Restoring Americans' Healthcare Freedom Reconciliation Act of 2015 Innovation For Healthier Americans H.R. 34 - 21st Century Cures Act ***, no specific bill(s), import safety, health care reform, 510K reform, medical device user fee program, companion diagnostics, user fee sequester S. 1077 - Advancing Breakthrough Medical Devices for Patients Act S. 1101 - Medical Electronic Data Technology Enhancement for Consumers Health Act S. 1767 - Combination Products Innovation Act S. 2700 - FDA and NIH Workforce Authorities Modernization Act S. 1101 - MEDTECH Act S. 1622 - FDA Device Accountability Act of 2015 S. 2737 - Improving Medical Device Innovation Act
Client expense: Not reported · Firm income: $70,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2016 · fourth_quarter · Pharmacy
Advise on standards-setting, verification, overseas programs and quality of medicines activities related to drugs, dietary supplements, biologics and food ingredients. S. 2700 FDA and NIH Workforce Authorities Modernization Act, section 11 - provisions related to biological product innovation Implementation of Public Law 111-148 Biologics Price Competition and Innovation Act; all provisions. H.R. 34, The 21st Century Cures Act; all provisons
Client expense: $110,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Health Issues
H.R. 6, H.R. 34 & Public Law 114-255, 21st Century Cures Act; S. 2700, FDA and NIH Workforce Authorities Modernization Act; H.R. 3381, Childhood Cancer STAR Act; Discussions to clarify or reform the 340B program; Biologics Price Competition and Innovation Act; Public Law 111-148, The Patient Protection and Affordable Care Act; Public Law 111-152, The Health Care and Education Reconciliation Act; H.R. 2228 & S.122, Safe and Affordable Drugs from Canada Act of 2015; Proposals to address prescription drug abuse; Implementation/Reauthorization of The Prescription Drug User Fee Act (PDUFA); Implementation/Reauthorization of The Biosimilars User Fee Act (BsUFA); H.R. 639 & S. 481, Improving Regulatory Transparency for New Medical Therapies; H.R. 2570 & S. 1396, Value-Based Insurance Design Seniors Copayment Reduction Act of 2015; H.R. 3012 & S. 2912, Trickett Wendler Right to Try Act of 2016; H.R. 6043 & S. 3335, Fair Accountability and Innovative Research Drug Pricing Act of 2016; S.3239, RACE for Children Act; Expanded Access (legislation not introduced) H.R. 4207, Medicare Fair Drug Pricing Act of 2015; Clinton's 1993 Health Security Act; S. 2023, Prescription Drug Affordability Act of 2015; H.R. 6501, Prescription Drug and Medical Device Price Review Board Act of 2016; S.3455, Pharmaceutical Supply and Value Enhancement Act; Repeal and Replace Proposals for Public Law 111-148, The Patient Protection and Affordable Care Act (no legislation introduced);
Client expense: $1,040,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health Resources & Services Administration (HRSA), Medicare Payment Advisory Commission (MedPAC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)
2016 · fourth_quarter · Health Issues
FDA and NIH Workforce Authorities Modernization Act, S. 2700.
Client expense: Not reported · Firm income: $80,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Health Issues
PL 111-148 - The Patient Protection and Affordable Care Act, implementation, comparative effectiveness H.R. 3204 - The Drug Quality and Security Act, implementation H.R. 6 - 21st Century Cures 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. 2680 - Mental Health Reform Act S. 1455 - Recovery Enhancement for Addiction Treatment Act S. 2256 - Co-Prescribing Saves Lives Act S. 480 - National All Schedules Prescription Electronic Reporting S. 2687 - Plan of Safe Care Improvement Act S. 1878 - Advancing Hope Act S. 1077 - Advancing Breakthrough Medical Devices for Patients Act S. 1101 - Medical Electronic Data Technology Enhancement for Consumers Health Act S. 2055 - Medical Countermeasures Innovation Act S. 1767 - Combination Products Innovation Act S. 1597 - Patient Focused Impact Assessment Act S. 2512 - Adding Zika Virus to FDA Priority Review Voucher Program Act S. 524 - The Comprehensive Addiction and Recovery Act of 2016 S. 2912 - Right to Try Act H.R. 34 - 21st Century Cures Act no specific bills, 340B, Innovation, A Better Way, Transparency, Precision Medicine, NIH, Importation
Client expense: Not reported · Firm income: $80,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2016 · fourth_quarter · Health Issues
PL 111-148 - The Patient Protection and Affordable Care Act, implementation PL 112-144 - The Food and Drug Administration Safety and Innovation Act, implementation H.R. 3204 - The Drug Quality and Security Act, implementation H.R. 6 - 21st Century Cures Innovation For Healthier Americans H.R. 34 - 21st Century Cures Act ***, no specific bills, FDA related issues, diagnostics, drug shortages, compounding, pandemic preparedness, innovation initiative, health IT S. 1077 - Advancing Breakthrough Medical Devices for Patients Act S. 1101 - Medical Electronic Data Technology Enhancement for Consumers Health Act S. 1767 - Combination Products Innovation Act S. 2700 - FDA and NIH Workforce Authorities Modernization Act S. 524/H.R. 953 - Comprehensive Addiction and Recovery Act of 2016
Client expense: Not reported · Firm income: $60,000
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2016 · fourth_quarter · Health Issues
S. 688 Establishing Beneficiary Equity in the Hospital Readmission Program Act of 2015. All provisions. H.R. 1343 Establishing Beneficiary Equity in Hospital Readmission Program Act of 2015. All provisions. Advance Notice of Methodological Changes for Calendar Year (CY) 2016 for Medicare Advantage (MA) Capitation Rates, Part C and Part D Payment Policies and 2016 Call Letter. All Provisions. P.L. 111-148 and P.L. 111-152 Affordable Care Act. All provisions related to implementation of health care reform including the Medicare and Medicaid programs, tax and insurance policies, graduate medical education, biomedical research, public and preventative health measures, and other policies concerning hospitals, physicians, health plans, employers and individuals. H.R. 6 - 21st Century Cures Act. All provisions. S. 1148 - The Resident Physician Shortage Reduction Act. All provisions. H.R. 2124 - The Resident Physician Shortage Reduction Act. All provisions. S. 2742 - The committee approved the Promoting Biomedical Research and Public Health for Patients Act S. 2700 - The FDA and NIH Workforce Authorities Modernization Act S. 185 - The Promise for Antiobiotics and Therapeutics for Health Act S. 2713 - The Advancing Precision Medicine Act of 2016 S. 2745 - The Advancing NIH Strategic Planning and Representation in Medical Research Act S. 2511 - Improving Health Information Technology Act P.L. 114-10 - Medicare Access and CHIP Reauthorization Act of 2015 - Centers for Medicare and Medicaid Proposed Rule. All provisions Centers for Medicare and Medicaid Services Proposed Medicare Part B Drug Payment Model All provisions. S. 524 - Comprehensive Addition and Recovery Act . All provisions. H.R. 5723 - Helping Hospital Improve Patient Care Act of 2016. All provisions. Centers for Medicare and Medicaid Services Outpatient Prospective Payment System proposed rule for calendar year 2017 implementing Section 603 of the Bipartisan Budget Act of 2015, "Treatment of Off-Campus Outpatient Departments of a Provider" - All provisions. H.R. 34 - 21st Century Cures Act, All Provisions UNOS Liver Allocation and Transplantation Policy
Client expense: $160,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2016 · fourth_quarter · Medical/Disease Research/Clinical Labs
H.R. 6 - 21st Century Cures Act. All provisions. S. 2742 - The committee approved the Promoting Biomedical Research and Public Health for Patients Act S. 2700 - The FDA and NIH Workforce Authorities Modernization Act S. 185 - The Promise for Antiobiotics and Therapeutics for Health Act S. 2713 - The Advancing Precision Medicine Act of 2016 S. 2745 - The Advancing NIH Strategic Planning and Representation in Medical Research Act S. 2511 - Improving Health Information Technology Act S. 524 - Comprehensive Addiction and Recovery Act. All provisions. H.R. 34 - 21st Century Cures Act, All Provisions
Client expense: $160,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2016 · fourth_quarter · Health Issues
PL 111-148 - The Patient Protection and Affordable Care Act, PL 111-152 - The Reconciliation Act of 2010, implementation, biosimilars, 340B, disclosure, comparative effectiveness research H.R. 6 - 21st Century Cures Innovation For Healthier Americans ***, no specific bill(s), health care reform, Biosimilars, PDUFA and related FDA policies, Innovation, 340B 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. 2680 - Mental Health Reform Act S. 1455 - Recovery Enhancement for Addiction Treatment Act S. 2256 - Co-Prescribing Saves Lives Act S. 480 - National All Schedules Prescription Electronic Reporting S. 2687 - Plan of Safe Care Improvement Act S. 1878 - Advancing Hope Act S. 1077 - Advancing Breakthrough Medical Devices for Patients Act S. 1101 - Medical Electronic Data Technology Enhancement for Consumers Health Act S. 2055 - Medical Countermeasures Innovation Act S. 1767 - Combination Products Innovation Act S. 1597 - Patient Focused Impact Assessment Act S. 2512 - Adding Zika Virus to FDA Priority Review Voucher Program Act S. 524 - The Comprehensive Addiction and Recovery Act of 2016 S. 2912 - Right to Try Act
Client expense: Not reported · Firm income: $80,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE
2016 · fourth_quarter · Health Issues
H.R. 34 - The 21st Century Cures Act H.R. 1537/S. 1878 - Advancing Hope Act of 2015 H.R. 3731 -RaD Fund Act S. 2030 - Advancing Targeted Therapies for Rare Diseases Act S. 1421 - OPEN Act H.R. 3742 - Access to Marketplace Insurance Act S. 1597 - Patient-Focused Impact Assessment Act of 2016 S. 1767 - Combination Product Regulatory Fairness Act of 2016 FDA Appropriations S. 2700 - FDA and NIH Workforce Authorities Modernization Act H.R. 4909 - Fiscal 2017 National Defense Authorization Act (NDAA) H.R. 3012 - Right to Try S. 2689 - REGROW Act H.R. 546/S. 298 - ACE Kids Act S. 3239 - RACE for Children Act Orphan Drug Tax Credit NIH Funding PDUFA MDUFA
Client expense: Not reported · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE, Social Security Administration (SSA)
2016 · third_quarter · Health Issues
Pharmaceutical innovation, precision medicine, rare diseases, platform technologies, Innovation For Healthier Americans H.R. 6 - 21st Century Cures S. 2030 - Advancing Targeted Therapies for Rare Diseases Act of 2015 S. 2700 - FDA and NIH Workforce Authorities Modernization Act S. 2713 - Advancing Precision Medicine Act of 2016 S. 2742 - Promoting Biomedical Research and Public Health for Patients Act S. 1878 - Advancing Hope Act S. 1597 - Patient Focused Impact Assessment Act S. 2912 - Right to Try Act
Client expense: $80,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2016 · first_quarter · Health Issues
H.R. 6, 21st Century Cures Act S. 2700, FDA and NIH Workforce Authorities Modernization Act; H.R. 3381, Childhood Cancer STAR Act; Discussions to clarify or reform the 340B program; Biologics Price Competition and Innovation Act; H.R. 1101 & S. 1287, Viral Hepatitis Testing Act; Public Law 111-148, The Patient Protection and Affordable Care Act; H.R. 471 & S. 483, Ensuring Patient Access and Effective Drug Enforcement of 2015; H.R. 1725 & S. 480, National All Schedules Prescription Electronic Reporting Reauthorization of 2015; H.R. 2228 & S.122, Safe and Affordable Drugs from Canada Act of 2015; Proposals to address prescription drug abuse; Implementation of The Prescription Drug User Fee Act (PDUFA); Implementation of The Biosimilars User Fee Act (BsUFA); Public Law 113-54, Drug Quality & Security Act; H.R. 639 & S. 481, Improving Regulatory Transparency for New Medical Therapies; H.R. 2570 & S. 1396, Value-Based Insurance Design Seniors Copayment Reduction Act of 2015; H.R. 3677 Opioid Abuse Prevention and Treatment Act of 2015; S. 524, Comprehensive Addiction and Recovery Act of 2016;
Client expense: $2,610,000 · 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), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)
2016 · third_quarter · Health Issues
21st Century Cures -S 2700: The FDA and NIH Workforce Authorities Modernization Act PDUFA/MDUFA Reauthorization -Patient Engagement -Real World Evidence Medicare Part B Demonstration
Client expense: Not reported · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2016 · third_quarter · Medicare/Medicaid
Monitor federal issues and legislation related to healthcare policy. Monitor federal issues and legislation related to Medicare reimbursement. Monitor implementation of Medicare Access and CHIP Reauthorization Act of 2015 (P.L. 114-10). Monitor implementation of the Patient Protection and Affordable Care Act (P.L. 111-148). Extend Section 3111, P.L. 111-148. Monitor the implementation of Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act, 2017, and Zika Response and Preparedness Act (P.L. 114-223). H.R. 6, House 21st Century Cures Act. H.R. 270, Flexibility in Health IT Reporting (Flex-IT) Act of 2015. H.R.775, Medicare Access to Rehabilitation Services Act of 2015. H.R. 1600, Patients' Access to Treatments Act of 2015. H.R. 1725, National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015. H.R. 1859, Ensuring Children's Access to Specialty Care Act of 2015. H.R. 2256, Veterans Information Modernization Act. H.R. 2464, Demanding Accountability for Veterans Act of 2015. H.R. 3020, House Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2015. H.R. 3309, Flex-IT 2 Act H.R. 4227, Medicare Advantage Bill of Rights. H.R. 4848, HIP Act H.R. 4909, National Defense Authorization Act for Fiscal Year 2017 H.R. 5001, Flexibility in Electronic Health Record Reporting Act. H.R. 5122, To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models. H.R. 5293, Department of Defense Appropriations, FY 2017. H.R.5721, Local Coverage Determination Clarification Act S. 480, National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015. S.539, Medicare Access to Rehabilitation Services Act of 2015. S. 2392, Medicare Advantage Bill of Rights. S. 2511, Improving Health Information Technology Act. S. 2822, Flexibility in Electronic Health Record Reporting Act S. 2943, National Defense Authorization Act for Fiscal Year 2017 S. 2978, The Protect Continuing Physician Education and Patient Care Act. S. 3000, Department of Defense Appropriations, FY 2017. S. 3040, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations, FY 2017. S.3173, EHR Regulatory Relief Act. Senate 21st Century Cures Act counterpart package, including S. 2700, S.185, S.2713, S.2745, S.2742, S.1878, S.1077, S.1101, S.2055, S.1767, S.1597, S.2512, S.2030, S.1622, S.2014, S.800, S.849, S.2503, and S.2511. Funding for NIH, CDC, DOD, related to arthritis and rheumatic disease research and education. Funding for Pediatric Subspecialty Loan Repayment Program. Draft, House Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations, FY 2017.
Client expense: $110,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2016 · third_quarter · Budget/Appropriations
Monitor federal issues and legislation related to healthcare policy. Monitor federal issues and legislation related to Medicare reimbursement. Monitor implementation of Medicare Access and CHIP Reauthorization Act of 2015 (P.L. 114-10). Monitor implementation of the Patient Protection and Affordable Care Act (P.L. 111-148). Extend Section 3111, P.L. 111-148. Monitor the implementation of Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act, 2017, and Zika Response and Preparedness Act (P.L. 114-223). H.R. 6, House 21st Century Cures Act. H.R. 270, Flexibility in Health IT Reporting (Flex-IT) Act of 2015. H.R.775, Medicare Access to Rehabilitation Services Act of 2015. H.R. 1600, Patients' Access to Treatments Act of 2015. H.R. 1725, National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015. H.R. 1859, Ensuring Children's Access to Specialty Care Act of 2015. H.R. 2256, Veterans Information Modernization Act. H.R. 2464, Demanding Accountability for Veterans Act of 2015. H.R. 3020, House Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2015. H.R. 3309, Flex-IT 2 Act H.R. 4227, Medicare Advantage Bill of Rights. H.R. 4848, HIP Act H.R. 4909, National Defense Authorization Act for Fiscal Year 2017 H.R. 5001, Flexibility in Electronic Health Record Reporting Act. H.R. 5122, To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models. H.R. 5293, Department of Defense Appropriations, FY 2017. H.R.5721, Local Coverage Determination Clarification Act S. 480, National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015. S.539, Medicare Access to Rehabilitation Services Act of 2015. S. 2392, Medicare Advantage Bill of Rights. S. 2511, Improving Health Information Technology Act. S. 2822, Flexibility in Electronic Health Record Reporting Act S. 2943, National Defense Authorization Act for Fiscal Year 2017 S. 2978, The Protect Continuing Physician Education and Patient Care Act. S. 3000, Department of Defense Appropriations, FY 2017. S. 3040, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations, FY 2017. S.3173, EHR Regulatory Relief Act. Senate 21st Century Cures Act counterpart package, including S. 2700, S.185, S.2713, S.2745, S.2742, S.1878, S.1077, S.1101, S.2055, S.1767, S.1597, S.2512, S.2030, S.1622, S.2014, S.800, S.849, S.2503, and S.2511. Funding for NIH, CDC, DOD, related to arthritis and rheumatic disease research and education. Funding for Pediatric Subspecialty Loan Repayment Program. Draft, House Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations, FY 2017.
Client expense: $110,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2016 · third_quarter · Health Issues
Monitor federal issues and legislation related to healthcare policy. Monitor federal issues and legislation related to Medicare reimbursement. Monitor implementation of Medicare Access and CHIP Reauthorization Act of 2015 (P.L. 114-10). Monitor implementation of the Patient Protection and Affordable Care Act (P.L. 111-148). Extend Section 3111, P.L. 111-148. Monitor the implementation of Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act, 2017, and Zika Response and Preparedness Act (P.L. 114-223). H.R. 6, House 21st Century Cures Act. H.R. 270, Flexibility in Health IT Reporting (Flex-IT) Act of 2015. H.R.775, Medicare Access to Rehabilitation Services Act of 2015. H.R. 1600, Patients' Access to Treatments Act of 2015. H.R. 1725, National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015. H.R. 1859, Ensuring Children's Access to Specialty Care Act of 2015. H.R. 2256, Veterans Information Modernization Act. H.R. 2464, Demanding Accountability for Veterans Act of 2015. H.R. 3020, House Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2015. H.R. 3309, Flex-IT 2 Act H.R. 4227, Medicare Advantage Bill of Rights. H.R. 4848, HIP Act H.R. 4909, National Defense Authorization Act for Fiscal Year 2017 H.R. 5001, Flexibility in Electronic Health Record Reporting Act. H.R. 5122, To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models. H.R. 5293, Department of Defense Appropriations, FY 2017. H.R.5721, Local Coverage Determination Clarification Act S. 480, National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015. S.539, Medicare Access to Rehabilitation Services Act of 2015. S. 2392, Medicare Advantage Bill of Rights. S. 2511, Improving Health Information Technology Act. S. 2822, Flexibility in Electronic Health Record Reporting Act S. 2943, National Defense Authorization Act for Fiscal Year 2017 S. 2978, The Protect Continuing Physician Education and Patient Care Act. S. 3000, Department of Defense Appropriations, FY 2017. S. 3040, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations, FY 2017. S.3173, EHR Regulatory Relief Act. Senate 21st Century Cures Act counterpart package, including S. 2700, S.185, S.2713, S.2745, S.2742, S.1878, S.1077, S.1101, S.2055, S.1767, S.1597, S.2512, S.2030, S.1622, S.2014, S.800, S.849, S.2503, and S.2511. Funding for NIH, CDC, DOD, related to arthritis and rheumatic disease research and education. Funding for Pediatric Subspecialty Loan Repayment Program. Draft, House Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations, FY 2017.
Client expense: $110,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), 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
HR: 6: 21st Century Cures Act; all provisions of the bill HR: 546: Advancing Care for Exceptional (ACE) Kids Act of 2015; all provisions of the bill HR: 605: Medicare Home Infusion Site of Care Act of 2015; all provisions of the bill HR: 4909: National Defense Authorization Act for Fiscal Year 2017; provisions related to Cystic Fibrosis care exemption HR: 5054: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017; provisions related to Food and Drug Administration funding HR: 5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2017, and Zika Response and Preparedness Act; provisions related to National Institutes of Health funding and Food and Drug Administration funding HR: 5926: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2017; provisions related to National Institutes of Health funding S. 185: Promised for Antibiotic and Therapeutics for Health (PATH) Act; all provisions of the bill S. 275: Medicare Home Infusion Site of Care Act of 2015; all provisions of the bill S. 298: Advancing Care for Exceptional (ACE) Kids Act of 2015; all provisions of the bill S. 1878: Advancing Hope Act of 2016; all provisions of the bill S. 2014: Next Generation Researchers Act; all provisions of the bill S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2016; all provisions of the bill S. 2511: Improving Health Information Technology Act; all provisions of the bill S. 2700: FDA and NIH Workforce Authorities Modernization Act; all provisions of the bill S. 2713: Advancing Precision Medicine Act of 2016; all provisions of the bill S. 2943: National Defense Authorization Act for Fiscal Year 2017; provisions related to Cystic Fibrosis care exemption S. 2956: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017; provisions related to Food and Drug Administration funding S. 3040: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2017; provisions related to National Institutes of Health funding General Discussions related to National Institutes of Health and Food and Drug Administration funding Discussions related to Prescription Drug User Fee Act VI; all provisions of the proposal
Client expense: $60,000 · Firm income: Not reported
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
2016 · third_quarter · Medical/Disease Research/Clinical Labs
HR: 6: 21st Century Cures Act; all provisions of the bill HR 5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2017, and Zika Response and Preparedness Act; provisions related to Food and Drug Administration and National Institutes of Health funding HR 5926: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2017; provisions related to National Institutes of Health, Agency for Healthcare Research & Quality, Centers for Medicare & Medicaid Services, and Patient-Centered Outcomes Research Institute funding S. 2014: Next Generation Researchers Act; all provisions of the bill S. 2700: FDA and NIH Workforce Authorities Modernization Act; all provisions of the bill S. 2713: Advancing Precision Medicine Act of 2016; all provisions of the bill S. 3040: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2017; provisions related to National Institutes of Health, Agency for Healthcare Research & Quality, Centers for Medicare & Medicaid Services, and Patient-Centered Outcomes Research Institute funding
Client expense: $60,000 · Firm income: Not reported
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
2016 · third_quarter · Health Issues
Monitor legislative and administrative action related to health care policy. Monitor legislative and administrative action related to drug user fees. Monitor legislative and administrative action related to dietary supplements. Monitor the implementation of the Patient Protection and Affordable Care Act, P.L. 111-148. Monitor legislative and administrative action related to FDAs Priority Review Voucher Program. S. 149, Medical Device Access and Innovation Protection Act. H.R. 6, 21st Century CURES Act. Senate 21st Century CURES Counterpart Package [S. 2700, S.185, S.2713, S.2745, S.2742, S.1878, S.1077, S.1101, S.2055, S.1767, S.1597, S.2512, S.2030, S.1622, S.2014, S.800, S.849, S.2503, and S.2511]. H.R. 160, Protect Medical Innovation Act of 2015. H.R. 1537, Advancing Hope Act of 2015.
Client expense: Not reported · Firm income: $120,000
Government targets: 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
Monitor implementation of the Patient Protection and Affordable Care Act (P.L. 111-148). Monitor federal and legislative activity related to Medicare Reimbursement. Monitor federal issues and legislation associated with health care policy. Monitor implementation of Medicare Access and CHIP Reauthorization Act of 2015 (P.L. 114-10). Monitor the implementation of Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act, 2017, and Zika Response and Preparedness Act (P.L. 114-223). H.R. 6, House 21st Century Cures Act. H.R. 270, Flexibility in Health IT Reporting (Flex-IT) Act of 2015. H.R.775, Medicare Access to Rehabilitation Services Act of 2015. H.R. 1600, Patients' Access to Treatments Act of 2015. H.R. 3309, Flex-IT 2 Act. H.R. 4227, Medicare Advantage Bill of Rights. H.R. 4848, HIP Act. H.R. 4909, National Defense Authorization Act for Fiscal Year 2017. H.R. 5001, Flexibility in Electronic Health Record Reporting Act. H.R. 5122, To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models. H.R. 5293, Department of Defense Appropriations, FY 2017. S.539, Medicare Access to Rehabilitation Services Act of 2015. S. 2392, Medicare Advantage Bill of Rights. S. 2511, Improving Health Information Technology Act. S. 2822, Flexibility in Electronic Health Record Reporting Act. S. 2943, National Defense Authorization Act for Fiscal Year 2017. S. 3000, Department of Defense Appropriations, FY 2017. S. 3040, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations, FY 2017. Senate 21st Century Cures Act counterpart package, including S. 2700, S.185, S.2713, S.2745, S.2742, S.1878, S.1077, S.1101, S.2055, S.1767, S.1597, S.2512, S.2030, S.1622, S.2014, S.800, S.849, S.2503, and S.2511. Draft, House Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations, FY 2017.
Client expense: Not reported · Firm income: $80,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · third_quarter · Budget/Appropriations
Monitor implementation of the Patient Protection and Affordable Care Act (P.L. 111-148). Monitor federal and legislative activity related to Medicare Reimbursement. Monitor federal issues and legislation associated with health care policy. Monitor implementation of Medicare Access and CHIP Reauthorization Act of 2015 (P.L. 114-10). Monitor the implementation of Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act, 2017, and Zika Response and Preparedness Act (P.L. 114-223). H.R. 6, House 21st Century Cures Act. H.R. 270, Flexibility in Health IT Reporting (Flex-IT) Act of 2015. H.R.775, Medicare Access to Rehabilitation Services Act of 2015. H.R. 1600, Patients' Access to Treatments Act of 2015. H.R. 3309, Flex-IT 2 Act. H.R. 4227, Medicare Advantage Bill of Rights. H.R. 4848, HIP Act. H.R. 4909, National Defense Authorization Act for Fiscal Year 2017. H.R. 5001, Flexibility in Electronic Health Record Reporting Act. H.R. 5122, To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models. H.R. 5293, Department of Defense Appropriations, FY 2017. S.539, Medicare Access to Rehabilitation Services Act of 2015. S. 2392, Medicare Advantage Bill of Rights. S. 2511, Improving Health Information Technology Act. S. 2822, Flexibility in Electronic Health Record Reporting Act. S. 2943, National Defense Authorization Act for Fiscal Year 2017. S. 3000, Department of Defense Appropriations, FY 2017. S. 3040, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations, FY 2017. Senate 21st Century Cures Act counterpart package, including S. 2700, S.185, S.2713, S.2745, S.2742, S.1878, S.1077, S.1101, S.2055, S.1767, S.1597, S.2512, S.2030, S.1622, S.2014, S.800, S.849, S.2503, and S.2511. Draft, House Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations, FY 2017.
Client expense: Not reported · Firm income: $80,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · third_quarter · Health Issues
Interoperability and Regulation of Health IT, including the SOFTWARE Act (H.R. 2396), MEDTECH Act (S. 1101), Improving Heath Information Technology Act (S. 3511), and 21st Century Cures Act (H.R. 6). Food and Drug Administration: drug, medical device, and agency reforms including improving scientific capacity at FDA and use of public-private partnerships (FDA and NIH Workforce Authorities Modernization Act, S. 2700); use of real-world evidence and drug development tools such as biomarkers and patient-reported outcomes (21st Century Cures Act, H.R. 6); and the approval process for certain items such as antibiotics (e.g., PATH Act, S. 185), treatments for unmet needs (e.g., Dormant Therapies Act of 2014, S. 3004, 113th Congress), combination products (e.g., S. 1767), and regenerative medicine/cellular therapies (REGROW Act, S. 2689/H.R. 4762). Medicare, including chronic care coordination, prevention, and health care delivery and payment reform Long-term care financing and Medicaid Money Follows the Person Rebalancing Demonstration program reauthorization Beneficiaries dually eligible for Medicare and Medicaid
Client expense: $260,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · third_quarter · Health Issues
H.R. 6, 21st Century Cures Act; S. 2700, FDA and NIH Workforce Authorities Modernization Act; Discussions to clarify or reform the 340B program; Biologics Price Competition and Innovation Act; H.R. 1101 & S. 1287, Viral Hepatitis Testing Act; Public Law 111-148, The Patient Protection and Affordable Care Act; H.R. 2228 & S.122, Safe and Affordable Drugs from Canada Act of 2015; Proposals to address prescription drug abuse; Implementation/Reauthorization of The Prescription Drug User Fee Act (PDUFA); Implementation/Reauthorization of The Biosimilars User Fee Act (BsUFA); H.R. 639 & S. 481, Improving Regulatory Transparency for New Medical Therapies; H.R. 2570 & S. 1396, Value-Based Insurance Design Seniors Copayment Reduction Act of 2015; H.R. 3677 Opioid Abuse Prevention and Treatment Act of 2015; S. 524, Comprehensive Addiction and Recovery Act of 2016; H.R. 3012 & S. 2912, Trickett Wendler Right to Try Act of 2016; H.R. 6043 & S. 3335, Fair Accountability and Innovative Research Drug Pricing Act of 2016; H.R. 6174, Closing Loopholes for Orphan Drugs Act; S.3239, RACE for Children Act; Expanded Access (legislation not introduced); H.R. 4207, Medicare Fair Drug Pricing Act of 2015; Clinton's 1993 Health Security Act;
Client expense: $1,920,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Medicare Payment Advisory Commission (MedPAC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)
2016 · third_quarter · Health Issues
H.R. 6, 21st Century Cures Act (Upton) - new cures and treatments H.R. 636, Federal Aviation Administration Reauthorization Act (Tiberi) - air ambulance amendments H.R. 691, Telehealth Modernization Act (Matsui-Johnson) - telemedicine H.R. 1189, Preserving Employee Wellness Programs Act (Kline) - employee wellness programs H.R. 2646, Helping Families in Mental Health Crisis Act (Murphy) - compliance with parity requirements, mental health services H.R. 2712, Commonsense Reporting and Verification Act (Black) - employer reporting and eligibility verification for ACA subsidies H.R. 2745, Standard Merger and Acquisition Reviews Through Equal Rules Act (Farenthold) - FTC-DOJ rules for reviewing mergers H.R. 3099, RAISE Family Caregivers Act (Harper) - national strategy to support family caregivers H.R. 3463, Aligning Childrens Dental Coverage Act (Griffith-DeGette) - rules for stand-alone dental plans H.R. 4276, Behavioral Health Coverage Transparency Act (Kennedy) - disclosure requirements relating to mental health parity H.R. 4641, Best Practices for Pain Management (Brooks) - HHS Task Force to review, revise, and disseminate best practices for pain management H.R. 4771, HEALTH Act (Franks) - medical liability reforms H.R. 5054, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies (Aderholt) - 21st Century Cures provisions S. 185, Promise for Antibiotics and Therapeutics for Health Act (Hatch) - FDA drug approval process S. 466, Quality Care for Moms and Babies Act (Stabenow) - pediatric quality measures S. 524, Comprehensive Addiction and Recovery Act (Whitehouse) - prescription opioid abuse S. 620, Preserving Employee Wellness Programs Act (Alexander) - employee wellness programs S. 961, Data Security Act (Carper) - data security S. 1077, Advancing Breakthrough Devices for Patients Act (Burr) - priority review of breakthrough medical devices S. 1427, Quality Measure Alignment Act (Stabenow) - facilitating coordination and alignment between public and private sectors on quality and efficiency measures S. 1719, RAISE Family Caregivers Act (Collins) - national strategy to support family caregivers S. 1996, Commonsense Reporting Act (Warner) - employer reporting and eligibility verification for ACA subsidies S. 2141, TRUST IT Act, (Cassidy) - health IT rating system S. 2646, Veterans Choice Improvement Act (Burr) - veterans health care S. 2680, Mental Health Reform Act (Alexander) - compliance with parity requirements, mental health services S. 2700, FDA and NIH Workforce Authorities Modernization Act (Alexander) - medical innovation amendments S. 3040, Labor, Health and Human Services, and Education Appropriations Act for fiscal year 2017 (Blunt) - funding for HHS programs and agencies, ACA risk corridors program S. 3244, Aligning Children's Dental Coverage Act (Roberts-Bennett) - rules for stand-alone dental plans Regulatory Issues: HIPAA administrative simplification issues, including standards for privacy, security, and electronic transactions and code sets (including ICD-10), identifiers including the health plan identifier, enforcement; cybersecurity; FEHBP enrollment data clearinghouse initiative, the enrollment reconciliation process, and a related OPM reimbursement factor for records that cannot be reconciled; issues relating to health insurance plan participation in FEHBP, including contract requirements; issues relating to similarly sized subscriber group (SSSG) and MLR requirements under the FEHBP; implementation of the health savings account provisions of the Medicare Act; issues related to Medicare Secondary Payer requirements; issues related to implementation of the National Health Information Infrastructure; electronic health records, personal health records, and similar technologies; issues relating to market consolidation; issues related to hospital consolidation; issues relating to quality improvement; issues related to potential priority research topics for the effective health care program; issues relating to the national health data stewardship; issues relating to hospital outpatient measurement and reporting; prescription drug pricing; issues relating to "meaningful use" requirements for health information technology; issues related to the collection of race and ethnicity data; issues related to medical loss ratios; reference pricing; review of rates for reasonableness; preexisting condition insurance plans; issues relating to antitrust; accountable care organizations; provider non-discrimination; coverage of preventive services; contraceptive coverage; pre-existing condition exclusions; lifetime and annual dollar limits on benefits; patient protections; grandfathered health plan provisions; issues relating to the annual fee on health insurance providers; health plan automatic enrollment requirements; issues related to qualified health plans including certification and rate filing templates; health insurance market rules; reinsurance, risk corridors, and risk adjustment (commonly referred to as the 3 Rs); dependent coverage; summary of benefits and coverage disclosures; benefit and payment parameters; essential health benefits, actuarial value, and accreditation; issues related to fraud, waste, abuse, Stark/Anti-Kickback laws and regulations; issues related to supplemental products; issues related to HIPAA excepted benefits; issues related to the federally-facilitated marketplaces (i.e., Exchanges/formerly referred to as the web portal); issues related to business continuity in relation to pandemics or natural events (e.g., hurricane, tornado, etc.); issues related to small employer group size; issues related to Certificate of Public Advantage; and other issues relating to health care reform implementation.
Client expense: $1,710,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), SENATE, Treasury, Dept of, White House Office
2016 · third_quarter · Health Issues
Monitor implementation of the Patient Protection and Affordable Care Act (P.L. 111-148). Monitor federal and legislative activity related to health care and reauthorization of National All Schedules Prescription Electronic Reporting Act (NASPER) (P.L. 109-60). Monitor federal and legislative activity related to Medicare Reimbursement. Monitor federal issues and legislation associated with health care policy. Monitor implementation of Medicare Access and CHIP Reauthorization Act of 2015 (P.L. 114-10). Monitor the implementation of Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act, 2017, and Zika Response and Preparedness Act (P.L. 114-223). H.R. 6, House 21st Century Cures Act. H.R. 1725, National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015. S. 480, National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015. H.R. 4227, Medicare Advantage Bill of Rights. S. 2392, Medicare Advantage Bill of Rights. H.R. 5046, Comprehensive Opioid Abuse Reduction Act of 2016. Senate 21st Century Cures Act counterpart package, including S. 2700, S.185, S.2713, S.2745, S.2742, S.1878, S.1077, S.1101, S.2055, S.1767, S.1597, S.2512, S.2030, S.1622, S.2014, S.800, S.849, S.2503, and S.2511. S. 3173, EHR Regulatory Relief Act. S. 3040, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations, FY 2017. Draft, House Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations, FY 2017.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · third_quarter · Budget/Appropriations
Monitor implementation of the Patient Protection and Affordable Care Act (P.L. 111-148). Monitor federal and legislative activity related to health care and reauthorization of National All Schedules Prescription Electronic Reporting Act (NASPER) (P.L. 109-60). Monitor federal and legislative activity related to Medicare Reimbursement. Monitor federal issues and legislation associated with health care policy. Monitor implementation of Medicare Access and CHIP Reauthorization Act of 2015 (P.L. 114-10). Monitor the implementation of Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act, 2017, and Zika Response and Preparedness Act (P.L. 114-223). H.R. 6, House 21st Century Cures Act. H.R. 1725, National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015. S. 480, National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015. H.R. 4227, Medicare Advantage Bill of Rights. S. 2392, Medicare Advantage Bill of Rights. H.R. 5046, Comprehensive Opioid Abuse Reduction Act of 2016. Senate 21st Century Cures Act counterpart package, including S. 2700, S.185, S.2713, S.2745, S.2742, S.1878, S.1077, S.1101, S.2055, S.1767, S.1597, S.2512, S.2030, S.1622, S.2014, S.800, S.849, S.2503, and S.2511. S. 3173, EHR Regulatory Relief Act. S. 3040, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations, FY 2017. Draft, House Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations, FY 2017.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · third_quarter · Medical/Disease Research/Clinical Labs
Monitor implementation of the Patient Protection and Affordable Care Act (P.L. 111-148). Monitor federal and legislative activity related to health care and reauthorization of National All Schedules Prescription Electronic Reporting Act (NASPER) (P.L. 109-60). Monitor federal and legislative activity related to Medicare Reimbursement. Monitor federal issues and legislation associated with health care policy. Monitor implementation of Medicare Access and CHIP Reauthorization Act of 2015 (P.L. 114-10). Monitor the implementation of Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act, 2017, and Zika Response and Preparedness Act (P.L. 114-223). H.R. 6, House 21st Century Cures Act. H.R. 1725, National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015. S. 480, National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015. H.R. 4227, Medicare Advantage Bill of Rights. S. 2392, Medicare Advantage Bill of Rights. H.R. 5046, Comprehensive Opioid Abuse Reduction Act of 2016. Senate 21st Century Cures Act counterpart package, including S. 2700, S.185, S.2713, S.2745, S.2742, S.1878, S.1077, S.1101, S.2055, S.1767, S.1597, S.2512, S.2030, S.1622, S.2014, S.800, S.849, S.2503, and S.2511. S. 3173, EHR Regulatory Relief Act. S. 3040, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations, FY 2017. Draft, House Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations, FY 2017.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · third_quarter · Medicare/Medicaid
Monitor implementation of the Patient Protection and Affordable Care Act (P.L. 111-148). Monitor federal and legislative activity related to health care and reauthorization of National All Schedules Prescription Electronic Reporting Act (NASPER) (P.L. 109-60). Monitor federal and legislative activity related to Medicare Reimbursement. Monitor federal issues and legislation associated with health care policy. Monitor implementation of Medicare Access and CHIP Reauthorization Act of 2015 (P.L. 114-10). Monitor the implementation of Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act, 2017, and Zika Response and Preparedness Act (P.L. 114-223). H.R. 6, House 21st Century Cures Act. H.R. 1725, National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015. S. 480, National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015. H.R. 4227, Medicare Advantage Bill of Rights. S. 2392, Medicare Advantage Bill of Rights. H.R. 5046, Comprehensive Opioid Abuse Reduction Act of 2016. Senate 21st Century Cures Act counterpart package, including S. 2700, S.185, S.2713, S.2745, S.2742, S.1878, S.1077, S.1101, S.2055, S.1767, S.1597, S.2512, S.2030, S.1622, S.2014, S.800, S.849, S.2503, and S.2511. S. 3173, EHR Regulatory Relief Act. S. 3040, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations, FY 2017. Draft, House Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations, FY 2017.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · third_quarter · Health Issues
H.R. 6 - The 21st Century Cures Act H.R. 1537/S. 1878 - Advancing Hope Act of 2015 H.R. 3731 -RaD Fund Act S. 2030 - Advancing Targeted Therapies for Rare Diseases Act S. 1421 - OPEN Act H.R. 3742 - Access to Marketplace Insurance Act S. 1597 - Patient-Focused Impact Assessment Act of 2016 S. 1767 - Combination Product Regulatory Fairness Act of 2016 FDA Appropriations S. 2700 - FDA and NIH Workforce Authorities Modernization Act H.R. 4909 - Fiscal 2017 National Defense Authorization Act (NDAA) Funding for Pediatric Device Consortia Grant Program H.R. 3012 - Right to Try S. 2689 - REGROW Act H.R. 546/S. 298 - ACE Kids Act S. 3239 - RACE for Children Act Orphan Drug Tax Credit Zika Funding CMS Medicare Part B Demonstration NIH Funding PDUFA
Client expense: Not reported · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE, Social Security Administration (SSA)
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
H.R. 1427/S. 804 - Medicare CGM Access Act of 2015 H.R. 6 - 21st Century Cures Act S. 2700 - FDA and NIH Workforce Authorities Modernization Act H.R. 1192/S. 586 - National Diabetes Clinical Care Commission Act
Client expense: $170,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · third_quarter · Pharmacy
Advise on standards-setting, verification, overseas programs and quality of medicines activities related to drugs, dietary supplements, biologics and food ingredients. S. 2700 FDA and NIH Workforce Authorities Modernization Act, section 11 - provisions related to biological product innovation Implementation of Public Law 111-148 Biologics Price Competition and Innovation Act; all provisions.
Client expense: $120,000 · Firm income: Not reported
Government targets: 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. 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 · Health Issues
Issues related to Senate Innovations Bill (S. 2700).
Client expense: Not reported · Firm income: $20,000
Government targets: SENATE
2016 · third_quarter · Health Issues
FDA and NIH Workforce Authorities Modernization Act, S. 2700.
Client expense: Not reported · Firm income: $80,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE