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Advancing Precision Medicine Act of 2016
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
Advancing Precision Medicine Act of 2016 (Sec. 2) This bill encourages the Department of Health and Human Services (HHS) to carry out a Precision Medicine Initiative to address disease prevention, diagnosis, and treatment. The initiative may include collection of health information from a diverse cohort of individuals. HHS may carry out specified activities relating to the initiative, including coordinating with the Department of Energy to address supercomputing needs. In implementing the initiative, HHS must: (1) collaborate with the National Institutes of Health (NIH), the Food and Drug Administration, and the Office of the National Coordinator for Health Information Technology; (2) implement secure data sharing; and (3) ensure inclusion of a broad range of participants, considering factors that contribute to health disparities. (Sec. 3) This bill amends the Public Health Service Act to revise provisions regarding disclosure by researchers of the identifiable, sensitive information of research subjects. HHS must prohibit researchers from disclosing such information from federally funded research to persons not connected to the research. Researchers may apply to have other research covered by this prohibition. Disclosures of such information are permitted if required by law, necessary for the medical treatment of the research subject, made with the consent of the subject, or made for the purposes of other research that is in compliance with regulations regarding protection of subjects. (Sec. 4) HHS may exempt identifiable information collected for biomedical research from disclosure under the Freedom of Information Act. (Sec. 5) The NIH may require recipients of grants or cooperative agreements to share scientific data. (Sec. 6) The NIH may approve requests by national research institutes to fund high-impact, cutting-edge research through transactions other than contracts, grants, or cooperative agreements. National research institutes must conduct and support high-risk, high-reward research.
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Filing registrants (30)
Placed on Senate Legislative Calendar under General Orders. Calendar No. 428.
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 · Budget/Appropriations
Funding for National Institutes of Health and other LHHS appropriations accounts (H.R.5926 and S.3040); 21st Century Cures Act (H.R.6 and H.R. 34); Senate Innovations Package (S.2713, S.2014, S.2745, S.2742)
Client expense: $250,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of the Vice President of the United States, SENATE, State, Dept of (DOS)
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 · 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 · 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.
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: $260,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
Client expense: $110,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
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
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
Issues related to access to rare and orphan disease therapeutics under the enactment of ACA (no specific bills); Issues related to FDA regulatory pathways for pharmaceuticals (no specific bills); H.R. 6 The 21st Century Care Act (all provisions); Issues related to the Senate "Innovation for Healthier Americans" Report (no specific bills);S. 2030 Advancing Targeted Therapies for Rare Disease Act of 2015; S.2713 Advancing Precision Medicine Act of 2016.
Client expense: $340,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2016 · fourth_quarter · Health Issues
S. 2713 the Advancing Precision Medicine Act of 2016 - establishes the Precision Medicine Initiative in statute, Precision Medicine, interoperability, Innovation for Healthier Americans - identifying opportunities for meaningful reform to our nation's medical product discovery and development, H.R. 34 - 21st Century Cures - better innovation, development and distribution of patient therapies
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE
2016 · fourth_quarter · Health Issues
Meaningful Use; mHealth; Telemedicine; H.R. 34 - 21st Century Cures - better innovation, development and distribution of patient therapies; Innovation for Healthier Americans - identifying opportunities for meaningful reform to our nation's medical product discovery and development; H.R. 3081/S. 1778 - TELEmedicine for MEDicare Act of 2015 - license portability for Medicare physicians to allow for better utilization of telehealth; S. 1101 - Medical Electronic Data Technology Enhancement for Consumers' Health Act - clarifying federal regulation for health IT products; H.R. 4442/S. 2484 - CONNECT for Health Act - issues relating to physician licensure; H.R. 2516/S.2170 - Veterans E-Health & Telemedicine Support Act of 2015 - license portability for VA physicians and contractors to allow for better utilization of telehealth; S. 2713 - Advancing Precision Medicine Act of 2016 - issues surrounding data standardization and interoperability; S. 2511 - Improving Health Information Technology Act - advancing interoperability within Meaningful Use program, HIPPA reforms to allow increased patient access to health information
Client expense: Not reported · Firm income: $40,000
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2016 · fourth_quarter · Budget/Appropriations
Funding for National Institutes of Health and other LHHS appropriations accounts (H.R.5926 and S.3040); 21st Century Cures Act (H.R.6 and H.R. 34); Senate Innovations Package (S.2713, S.2014, S.2745, S.2742)
Client expense: $145,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of the Vice President of the United States, SENATE, State, Dept of (DOS)
2016 · fourth_quarter · Health Issues
Prevention & Public Health Fund (PPHF) - support for funding/implementation of the ACA, including NECELC; support for S. 2713, the Advancing Precision Medicine Act of 2016; support for maintaining child nutrition reauthorization, specifically CACFP, school lunch and breakfast programs; support for S. 2680, the Mental Health Reform Act of 2016; support for Reducing Obesity in Youth Act S.3194; support for H.R. 4524, the Children's CARE Act; and discussions on S.298/HR 546 ACE Kids Act; S. 2821 True LEADership Act of 2016; S.689 Sports Medicine licensing; CHIPRA (no bill #); Race for Kids Act S.3239, H.R. 5858;Stabilize Medicaid and CHIP Coverage Act of 2015 (SMCA) - H.R.700/ S.428; P.L. 114-255 21st Century Cures Act (biomedical research and mental health provisions for children)
Client expense: $86,077 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2016 · fourth_quarter · Medical/Disease Research/Clinical Labs
S. 289/H.R. 2104 American Cures Act, entire bill. S. 318/H.R. 531 Accelerating Biomedical Research Act, entire bill. H.R. 6, 21st Century Cures Act, Title I and II. H.R. 2124/S. 1148, Resident Physician Shortage Reduction Act, entire bill. S. 2713, Advancing Precision Medicine Act of 2016, entire bill. H.R. 34, 21st Century Cures Act.
Client expense: $147,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Health Issues
General healthcare. Health reform implementation. Healthcare value and quality. Health information technology, clinical trials, telehealth. Precision medicine, delivery system reform. S. 2713, Advancing Precision Medicine Act of 2016. H.R. 6, 21st Century Cures Act. Moonshot Cancer Initiative. S. 2742, Promoting Biomedical Research and Public Health for Patients Act. S. 2745, Advancing NIH Strategic Planning and Representation in Medical Research Act.
Client expense: Not reported · Firm income: $60,000
Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Science & Technology Policy (OSTP), SENATE
2016 · fourth_quarter · Health Issues
S 1077 Advancing Breakthrough Devices for Patients S2014 HR3466 Next Generation Researchers Act HR 3731, S 2030 Rare Disease Fund Act of 2015 S 2624 National Biomedical Research Act S 1878 Advancing Hope Act of 2015 S 2055 Medical Countermeasure Innovation Act of 2016 S 1622 FDA Device Accountability Act S 849 Advancing Research for Neurological Diseases Act of 2015 S 800 Enhancing the Stature and Visibility of Medical Rehabilitation Research at the NIH Act S 2713 Advancing Precision Medicine Act of 2016 S 2745 NIH Strategic Plan and Inclusion in Clinical Research S 2472 Promoting Biomedical Research and Public Health for Patients Act (to reduce regulatory burden on NIH-funded researchers) HR 34 21st Century Cures Act (formerly HR 6), signed into law
Client expense: $38,669 · Firm income: Not reported
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
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
The 21st Century Cures Act included in H. R. 2028, Further Continuing and Security Assistance Appropriations Act for Fiscal Year 2017; issues related to the implementation and adoption of health information technology, genomics, and precision medicine, including S.2713, The Advancing Precision Medicine Act of 2016. Issues related to remote patient monitoring including S.2484 and H.R. 4442, The CONNECT for Health Act. Issues related to the Vice President's Cancer Moonshot Initiative, telehealth, and health care technology including the Collaborative Cancer Cloud.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Medical/Disease Research/Clinical Labs
S. 289/H.R. 2104 American Cures Act, entire bill. S. 318/H.R. 531 Accelerating Biomedical Research Act, entire bill. H.R. 6, 21st Century Cures Act, Title I and II. H.R. 2124/S. 1148, Resident Physician Shortage Reduction Act, entire bill. S. 2713, Advancing Precision Medicine Act of 2016, entire bill. H.R. 34, 21st Century Cures Act.
Client expense: $168,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Medical/Disease Research/Clinical Labs
S. 289/H.R. 2104 American Cures Act, entire bill. S. 318/H.R. 531 Accelerating Biomedical Research Act, entire bill. H.R. 6, 21st Century Cures Act, Title I and II. H.R. 2124/S. 1148, Resident Physician Shortage Reduction Act, entire bill. S. 2713, Advancing Precision Medicine Act of 2016, entire bill. H.R. 34, 21st Century Cures Act.
Client expense: $168,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Pharmacy
Precision Medicine Act (S2713); General Pharmacy Issues (HR6/2713); opioid abuse (S524, HR953, HR2805, HR4499); specialty drug pricing
Client expense: $30,000 · 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 · Science/Technology
HR. 8 North American Energy Security and Infrastructure Act H.R. 1806 America COMPETES Act Reauthorization Act H.R. 3537 Synthetic Drug Control Act H.R. 4783 Commercializing on Small Business Innovation Act H.R. 4909 National Defense Authorization Act H.R. 5583 University Regulation Streamlining and Harmonization Act S. 185 Promise for Antibiotics and Therapeutics for Health Act S. 771 Manufacturing Universities Act S. 2012 Energy Policy and Modernization Act S. 2089 American Energy Innovation Act S. 2658 Federal Aviation Administration (FAA) Modernization Act S. 2713 Advancing Precision Medicine Act of 2016 S. 2742 Promoting Biomedical Research and Public Health for Patients Act S. 2745 Advancing NIH Strategic Planning and Representation in Medical Research Act S. 2793 SBIR/STTR Reauthorization Act S. 2812 SBIR and STTR Reauthorization and Improvement Act S. 2898 Small Business National Security Innovation Act S. 2943 National Defense Authorization Act S. 3084, American Innovation and Competitiveness Act S. 3224 Synthetic Drug Control Act S. 3346 The NASA Transition Authorization Act -- regarding research-related funding and policy issues affecting higher education institutions
Client expense: $10,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Health Issues
Affordable Care Act (ACA) Issues; ACA Regulations; Postal Reform; Department of Labor Conflict of Interest Rule; HCR Implementation; Health Savings Accounts (HSAs); Re-insurance; Co-ops; Notice of Benefit and Payment Parameters (NBPP); Health Care Bill; Market Stability; Year-end Priorities; Cost-sharing Reduction (CSR); Better Way; Repeal/Replace Modeling; ACA Reform; Risk Corridors; Chronic Care; Comprehensive Care and Recovery Act (CARA); Mental Health Reform; Premium Education; Third Party Payment of Premiums; Association Health Plans; SEPs; Grace Periods; Age Bands. HR 928 Introduced February 12, 2015 by Charles Boustany (R-LA) This bill repeals a provision of the Patient Protection and Affordable Care Act that imposes an annual fee on a health insurance provider based on its net premium income. HR 1934 Cancer Care Payment Reform Act of 2015 Introduced April 22, 2015 by Cathy McMorris Rodgers To amend title XVIII of the Social Security Act to establish a national Oncology Medical Home Demonstration Project under the Medicare program for the purpose of changing the Medicare payment for cancer care in order to enhance the quality of care and to improve cost efficiency, and for other purposes. HR 2488 Medicare Beneficiary Preservation of Choice Act of 2015 Introduced May 21, 2015 by Keith Rothfus (R-PA) This bill amends title XVIII (Medicare) of the Social Security Act to expand and modify enrollment and disenrollment options for Medicare Advantage (MA) eligible individuals. Specifically, the bill extends the annual period in which an individual enrolled in MA may elect to instead receive benefits under the original Medicare fee-for-service (FFS) program as well as elect to change qualified prescription drug coverage. Furthermore, any MA-eligible individual (whether or not enrolled in MA) may once per period change a previous election with respect to receiving benefits through MA or Medicare FFS, including changing from one MA plan to another. Unsolicited marketing during this period is prohibited. HR 2646 Helping Families in Mental Health Crisis Act of 2015 Introduced May 4, 2015 by Tim Murphy (R-PA) To make available needed psychiatric, psychological, and supportive services for individuals with mental illness and families in mental health crisis, and for other purposes. HR 3244 Providing Innovative Care for Complex Cases Demonstration Act of 2015 Introduced July 28, 2015 by Cathy McMorris Rodgers (R-WA) To amend title XVIII of the Social Security Act to establish a pilot program to improve care for the most costly Medicare fee-for-service beneficiaries through the use of comprehensive and effective care management while reducing costs to the Federal Government for these beneficiaries, and for other purposes. HR 3463 Aligning Childrens Dental Coverage Act Introduced September 9, 2015 by H. Griffith (R-VA) To amend title XXVII of the Public Health Service Act to clarify the treatment of pediatric dental coverage in the individual and group markets outside of Exchanges established under the Patient Protection and Affordable Care Act, and for other purposes as introduced. HR 3742 Access to Marketplace Insurance Act Introduced October 9, 2015 by Kevin Cramer (R-ND) To amend the Patient Protection and Affordable Care Act to allow for certain third party payments. HR 4275 Medicare Advantage Quality Payment Relief Act of 2015 Introduced December 16, 2015 by Mike Kelly (R-PA) To amend title XVIII of the Social Security Act to eliminate a provision under the Medicare Advantage program that inadvertently penalizes Medicare Advantage plans for providing high quality care to Medicare beneficiaries. HR 5273 Helping Hospitals Improve Patient Care Act of 2016 Introduced May 18, 2016 by Patrick Tiberi (R-OH) To amend title XVIII of the Social Security Act to provide for regulatory relief under the Medicare program for certain providers of services and suppliers and increased transparency in hospital coding and enrollment data, and for other purposes. HR 5410 Health Coverage State Flexibility Act of 2016 Introduced June 8, 2016 by Bill Flores (R-TX) to amend the Patient Protection and Affordable Care Act to better align the grace period required for non-payment of premiums before discontinuing coverage under qualified health plans with such grace periods provided for under State law. HR 5447 Small Business Health Care Relief Act of 2016 Introduced June 21, 2016 by Charles Boustany, Jr. (R-LA) To provide an exception from certain group health plan requirements for qualified small employer health reimbursement arrangements. HR 5506 Introduced June 15, 2016 by Todd Young (R-IN) To amend title XVIII of the Social Security Act to establish a demonstration program to provide integrated care for Medicare beneficiaries with end-stage renal disease, and for other purposes. HR 5547 Health Care Price Transparency Promotion Act of 2016 Introduced by Michael Burgess (R-IN) To amend title XIX of the Social Security Act to provide for increased price transparency of hospital information and to provide for additional research on consumer information on charges and out-of-pocket costs. HR 5589 Plan Verification and Fairness Act of 2016 Introduced June 28, 2016 by Marsha Blackburn (R-TN) To amend title I of the Patient Protection and Affordable Care Act to require verification for eligibility for enrollment during special enrollment periods in PPACA insurance plans, and for other purposes. HR 5904 Tax Payers Before Insurers Act Introduced July 14, 2016 by Mark Walker (R-NC) To require the Secretary of Health and Human Services to deposit certain funds into the general fund of the Treasury in accordance with provisions of Federal law with regard to the Patient Protection and Affordable Care Act's Transitional Reinsurance Program. HR 5921 State Age Rating Flexibility Act Introduced July 21, 2016 by Larry Bucshon (R-IN) To amend title XXVII of the Public Health Service Act to change the permissible age variation in health insurance premium rates. S. 524 Comprehensive Addiction and Recovery Act of 2016 Introduced February 12, 2015 by Sheldon Whitehouse (D-RI) Overdoses from heroin, prescription drugs, and opioid pain relievers last year surpassed car accidents as the leading cause of injury-related death in America, according to the Centers for Disease Control. Deaths have reached their highest levels of the 21st century in 2014, the most recent year for which data is available, according to the National Institute on Drug Abuse. Heroin overdoses have more than tripled in the last five years, an issue receiving outsize attention nationally but especially during the presidential campaign season as New Hampshire has been one of the hardest-hit states. S. 1697 Small Business Healthcare Relief Act Introduced June 25, 2015 by Charles Grassley (R-IA) A bill to provide an exception from certain group health plan requirements to allow small businesses to use pre-tax dollars to assist employees in the purchase of policies in the individual health insurance market, and for other purposes. S. 1945 Mental Health Reform Act of 2015 Introduced August 5, 2015 by Bill Cassidy (R-LA) A bill to make available needed psychiatric, psychological, and supportive services for individuals with mental illness and families in mental health crisis, and for other purposes. S. 2713 Introduced March 17, 2016 by Lamar Alexander (R-TN) Advancing Precision Medicine Act of 2016 A bill to provide for the implementation of a Precision Medicine Initiative
Client expense: $2,160,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
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 · third_quarter · Health Issues
Affordable Care Act Issues: Chronic Care Innovations; Payment Reform; 2017 Notice of Benefit and Payment Parameters (NBPP); ACA Regulations; Co-ops; Implementation; Market Stability; Department of Labor Conflict of Interest Rule; Grace Periods; Special Enrollment Periods (SEPs); Reinsurance; Risk Corridors; Risk Mitigation; Risk Programs; Premiums; Health Reimbursement Arrangements (HRAs) Legislation; Individual Market Reform; Third-Party Payments; Exchanges;; Age Bands. Other Health Care Issues -- Mental Health Reform; End Stage Renal Disease (ESRD); Zika Virus; Postal Reform; Health Savings Accounts HR 928 Introduced February 12, 2015 by Charles Boustany (R-LA) This bill repeals a provision of the Patient Protection and Affordable Care Act that imposes an annual fee on a health insurance provider based on its net premium income. HR 2646 Helping Families in Mental Health Crisis Act of 2015 Introduced May 4, 2015 by Tim Murphy (R-PA) To make available needed psychiatric, psychological, and supportive services for individuals with mental illness and families in mental health crisis, and for other purposes. HR 3742 Access to Marketplace Insurance Act Introduced October 9, 2015 by Kevin Cramer (R-ND) To amend the Patient Protection and Affordable Care Act to allow for certain third party payments. HR 5410 Health Coverage State Flexibility Act of 2016 Introduced June 8, 2016 by Bill Flores (R-TX) to amend the Patient Protection and Affordable Care Act to better align the grace period required for non-payment of premiums before discontinuing coverage under qualified health plans with such grace periods provided for under State law. HR 5447 Small Business Health Care Relief Act of 2016 Introduced June 21, 2016 by Charles Boustany, Jr. (R-LA) To provide an exception from certain group health plan requirements for qualified small employer health reimbursement arrangements. HR 5506 Introduced June 15, 2016 by Todd Young (R-IN) To amend title XVIII of the Social Security Act to establish a demonstration program to provide integrated care for Medicare beneficiaries with end-stage renal disease, and for other purposes. HR 5547 Health Care Price Transparency Promotion Act of 2016 Introduced by Michael Burgess (R-IN) To amend Title XIX of the Social Security Act to provide for increased price transparency of hospital information and to provide for additional research on consumer information on charges and out-of-pocket costs. HR 5589 Plan Verification and Fairness Act of 2016 Introduced June 28, 2016 by Marsha Blackburn (R-TN) To amend Title I of the Patient Protection and Affordable Care Act to require verification for eligibility for enrollment during special enrollment periods in PPACA insurance plans, and for other purposes. H.R. 5904 Tax Payers Before Insurers Act Introduced July 14, 2016 by Mark Walker (R-NC) To require the Secretary of Health and Human Services to deposit certain funds into the general fund of the Treasury in accordance with provisions of Federal law with regard to the Patient Protection and Affordable Care Act's Transitional Reinsurance Program. H.R. 5921 State Age Rating Flexibility Act Introduced July 21, 2016 by Larry Bucshon (R-IN) To amend Title XXVII of the Public Health Service Act to change the permissible age variation in health insurance premium rates. S. 524 Comprehensive Addiction and Recovery Act of 2016 Introduced February 12, 2015 by Sheldon Whitehouse (D-RI) Overdoses from heroin, prescription drugs, and opioid pain relievers last year surpassed car accidents as the leading cause of injury-related deaths in America, according to the Centers for Disease Control. Deaths have reached their highest levels of the 21st century in 2014, the most recent year for which data is available, according to the National Institute on Drug Abuse. Heroin overdoses have more than tripled in the last five years, an issue receiving outsize attention nationally but especially during the presidential campaign season as New Hampshire has been one of the hardest-hit states. S. 1697 Small Business Healthcare Relief Act Introduced June 25, 2015 by Charles Grassley (R-IA) A bill to provide an exception from certain group health plan requirements to allow small businesses to use pre-tax dollars to assist employees in the purchase of policies in the individual health insurance market, and for other purposes. S. 1945 Mental Health Reform Act of 2015 Introduced August 5, 2015 by Bill Cassidy (R-LA) A bill to make available needed psychiatric, psychological, and supportive services for individuals with mental illness and families in mental health crisis, and for other purposes. S. 2713 Introduced March 17, 2016 by Lamar Alexander (R-TN) Advancing Precision Medicine Act of 2016 A bill to provide for the implementation of a Precision Medicine Initiative.
Client expense: Not reported · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · second_quarter · Science/Technology
HR. 8 North American Energy Security and Infrastructure Act H.R. 1806 America COMPETES Act Reauthorization Act H.R. 3537 Synthetic Drug Control Act H.R. 4783 Commercializing on Small Business Innovation Act H.R. 4909 National Defense Authorization Act H.R. 5583 University Regulation Streamlining and Harmonization Act S. 3346 The NASA Transition Authorization Act S. 185 Promise for Antibiotics and Therapeutics for Health Act S. 771 Manufacturing Universities Act S. 2012 Energy Policy and Modernization Act S. 2089 American Energy Innovation Act S. 2658 Federal Aviation Administration (FAA) Modernization Act S. 2713 Advancing Precision Medicine Act of 2016 S. 2742 Promoting Biomedical Research and Public Health for Patients Act S. 2745 Advancing NIH Strategic Planning and Representation in Medical Research Act S. 2793 SBIR/STTR Reauthorization Act S. 2812 SBIR and STTR Reauthorization and Improvement Act S. 2898 Small Business National Security Innovation Act S. 2943 National Defense Authorization Act S. 3084 American Innovation and Competitiveness Act S. 3224 Synthetic Drug Control Act -- regarding research-related funding and policy issues affecting higher education institutions
Client expense: $15,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, 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
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
General healthcare. Health reform implementation. Healthcare value and quality. Health information technology, clinical trials, telehealth. Precision medicine, delivery system reform. S. 2713, Advancing Precision Medicine Act of 2016. H.R. 6, 21st Century Cures Act. Moonshot Cancer Initiative. S. 2742, Promoting Biomedical Research and Public Health for Patients Act. S. 2745, Advancing NIH Strategic Planning and Representation in Medical Research Act.
Client expense: Not reported · Firm income: $60,000
Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Science & Technology Policy (OSTP), SENATE
2016 · third_quarter · Health Issues
Issues related to access to rare and orphan disease therapeutics under the enactment of ACA (no specific bills); Issues related to FDA regulatory pathways for pharmaceuticals (no specific bills); H.R. 6 The 21st Century Care Act (all provisions); Issues related to the Senate "Innovation for Healthier Americans" Report (no specific bills);S. 2030 Advancing Targeted Therapies for Rare Disease Act of 2015; S.2713 Advancing Precision Medicine Act of 2016.
Client expense: $350,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2016 · third_quarter · Health Issues
Issues related to H.R. 6, the 21st Century Cures Act and the Senate Innovations for Healthier Americans initiative; issues related to the implementation and adoption of health information technology, genomics, and precision medicine, including S.2713, The Advancing Precision Medicine Act of 2016. Issues related to remote patient monitoring including S.2484 and H.R. 4442, The CONNECT for Health Act. Issues related to the Vice President's Cancer Moonshot Initiative, telehealth, and health care technology including the Collaborative Cancer Cloud.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)
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 · 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
HR 6 21st Century Cures S 1077 Advancing Breakthrough Devices for Patients S2014 HR3466 Next Generation Researchers Act HR 3731, S 2030 Rare Disease Fund Act of 2015 S 2624 National Biomedical Research Act S 1878 Advancing Hope Act of 2015 S 2055 Medical Countermeasure Innovation Act of 2016 S 1622 FDA Device Accountability Act S 849 Advancing Research for Neurological Diseases Act of 2015 S 800 Enhancing the Stature and Visibility of Medical Rehabilitation Research at the NIH Act S 2713 Advancing Precision Medicine Act of 2016 S 2745 NIH Strategic Plan and Inclusion in Clinical Research S 2472 Promoting Biomedical Research and Public Health for Patients Act (to reduce regulatory burden on NIH-funded researchers)
Client expense: $58,768 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · third_quarter · Health Issues
S. 2713 the Advancing Precision Medicine Act of 2016 - establishes the Precision Medicine Initiative in statute, Precision Medicine, interoperability, Innovation for Healthier Americans - identifying opportunities for meaningful reform to our nation's medical product discovery and development, H.R. 6 - 21st Century Cures - better innovation, development and distribution of patient therapies
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE
2016 · third_quarter · Health Issues
Meaningful Use; mHealth; Telemedicine; H.R. 6 - 21st Century Cures - better innovation, development and distribution of patient therapies; Innovation for Healthier Americans - identifying opportunities for meaningful reform to our nation's medical product discovery and development; H.R. 3081/S. 1778 - TELEmedicine for MEDicare Act of 2015 - license portability for Medicare physicians to allow for better utilization of telehealth; S. 1101 - Medical Electronic Data Technology Enhancement for Consumers' Health Act - clarifying federal regulation for health IT products; H.R. 4442/S. 2484 - CONNECT for Health Act - issues relating to physician licensure; H.R. 2516/S.2170 - Veterans E-Health & Telemedicine Support Act of 2015 - license portability for VA physicians and contractors to allow for better utilization of telehealth; S. 2713 - Advancing Precision Medicine Act of 2016 - issues surrounding data standardization and interoperability; S. 2511 - Improving Health Information Technology Act - advancing interoperability within Meaningful Use program, HIPPA reforms to allow increased patient access to health information
Client expense: Not reported · Firm income: $40,000
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2016 · third_quarter · Health Issues
Affordable Care Act - Chronic Care Innovations; Payment reform; CBPP; 2017 Notice of Benefit and Payment Parameters; ACA Regulations, Implementation; Open Enrollment; Market Stability; Special Enrollment Periods (SEPs); Reinsurance; Risk corridors; Risk Mitigation; Risk Programs; Premiums; Individual Market Reform; Third party payments; Exchanges; Age Bands. Other Health Care Issues- Mental Health Reform; End Stage Renal Disease (ESRD); Health Savings Accounts; Opioid Education. HR 2488 Medicare Beneficiary Preservation of Choice Act of 2015 Introduced May 21, 2015 by Keith Rothfus (R-PA) This bill amends title XVIII (Medicare) of the Social Security Act to expand and modify enrollment and disenrollment options for Medicare Advantage (MA) eligible individuals. Specifically, the bill extends the annual period in which an individual enrolled in MA may elect to instead receive benefits under the original Medicare fee-for-service (FFS) program as well as elect to change qualified prescription drug coverage. Furthermore, any MA-eligible individual (whether or not enrolled in MA) may once per period change a previous election with respect to receiving benefits through MA or Medicare FFS, including changing from one MA plan to another. Unsolicited marketing during this period is prohibited. HR 928 Introduced February 12, 2015 by Charles Boustany (R-LA). This bill repeals a provision of the ACA that imposes an annual fee on a health insurance provider based on its net premium income. HR 2646 Helping Families in Mental Health Crisis Act of 2015 Introduced May 4, 2015 by Tim Murphy (R-PA) To make available needed psychiatric, psychological, and supportive services for individuals with mental illness and families in mental health crisis, and for other purposes. HR 3742 Access to Marketplace Insurance Act Introduced October 9, 2015 by Kevin Cramer (R-ND) To amend the Patient Protection and Affordable Care Act to allow for certain third party payments. HR 5410 Health Coverage State Flexibility Act of 2016, Introduced June 21, 2016 by Bill Flores (R-TX), Amends the Patient Protection and Affordable Care Act to revise the grace period that health insurers must provide to recipients of premium subsidies before discontinuing health coverage for nonpayment of premiums. HR 5506 Introduced June 15, 2016 by Todd Young (R-IN) To amend title XVIII of the Social Security Act to establish a demonstration program to provide integrated care for Medicare beneficiaries with end-stage renal disease, and for other purposes. HR 5589 Plan Verification and Fairness Act of 2016 Introduced June 28, 2016 by Marsha Blackburn (R-TN) To amend title I of the Patient Protection and Affordable Care Act to require verification for eligibility for enrollment during special enrollment periods in PPACA insurance plans, and for other purposes. HR 5904 Tax Payers Before Insurers Act Introduced July 14, 2016 by Mark Walker (R-NC) To require the Secretary of Health and Human Services to deposit certain funds into the general fund of the Treasury in accordance with provision of Federal law with regard to the Patient Protection and Affordable Care Acts Transitional reinsurance Program. HR 5921 State Age Rating Flexibility Act Introduced July 21, 2016 by Larry Bucshon (R-IN) To amend title XXVII of the Public Health Services Act to change the permissible age variation in health insurance premium rates. S. 524 Comprehensive Addition and Recovery Act of 2016 Introduced February 12, 2015 by Sheldon Whitehouse (D-RI) Overdoes from heroin, prescription drugs, and opioid pain relievers. Overdoses from heroin, prescription drugs, and opioid pain relievers last year surpassed car accidents as the leading cause of injury-related death in America, according to the Centers for Disease Control. Deaths have reached their highest levels of the 21st century in 2014, the most recent year for which data is available, according to the National Institute on Drug Abuse. The bill authorizes the Attorney General and Secretary of Health and Human Services to award grants to address the national epidemics of prescription opioid abuse and heroin use. S. 1945 Mental Health Reform Act of 2015 Introduced August 5, 2015 by Bill Cassidy (R-LA) A bill to make available needed psychiatric, psychological and supportive services for individuals with mental illness and families in mental health crisis, and for other purposes. S. 2713 Introduced March 17, 2016 by Lamar Alexander (R-TN) Advancing Precision Medicine Act of 2016 A bill to provide for the implementation of Precision Medicine Initiative. Network Adequacy standards and network tiering.
Client expense: $30,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · third_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
Client expense: Not reported · Firm income: $80,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE