PATH Act

S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 289: American Cures Act - Provisions related to National Institutes of Health (NIH) funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 2615: Increasing Competition in Pharmaceuticals Act - Provisions related to FDA review of generic drugs and study on risk evaluation and mitigation strategies (REMS) program S. 2680: Mental Health Reform Act of 2016 - Provisions related to mental health issues S. 2689: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments S. 2700: FDA and NIH Workforce Modernization Act - Provisions related to FDA and NIH S. 2912: Trickett Wendler Right to Try Act of 2016 - A bill to authorize the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law, and for other purposes - Provisions related to use of unapproved medical products by patients with a terminal illness S. 3056: CREATES Act of 2016 - Provisions related to access to samples of prescription drugs S. 3335: Fair Accountability and Innovative Research (FAIR) Drug Pricing Act - Provisions relating to transparency H.R. 6 / H.R. 34: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2805: Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 - Provisions related to the treatment of heroin and prescription opioid abuse H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 or FAST Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing H.R. 3012: Right to Try Act of 2015 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 3381: Childhood Cancer STAR Act - Provisions related to expanded access and other issues H.R. 4762: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments H.R. 4784: Lower Drug Costs Through Competition Act - Provisions related to generic drugs and priority review vouchers; REMS study; and tropical disease product applications H.R. 5122: A bill to prohibit further action on the proposed rule regarding testing of Medicare Part B prescription drug models H.R. 5858: The RACE for Children Act - Provisions related to pediatric studies H.R. 6043: Fair Accountability and Innovative Research (FAIR) Drug Pricing Act of 2016 - Provisions related to transparency H.R. 6174: Closing Loopholes for Orphan Drugs Act - Provisions relating to 340B discounts on orphan drugs Kids Innovative Drugs Act (draft) - Incentives for the development of pediatric oncology drugs The Regenerative Medicine Regulatory Improvement Act (discussion draft) - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) - Incentives for the development of pediatric drugs Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Proposed HRSA 340B program mega-guidance - Provisions related to 340B program Implementation and other issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges 340B Drug Discount Program policy issues General FDA advocacy including sharing of truthful and non-misleading information about medicines with healthcare professionals Prescription Drug User Fee Act (PDUFA) reauthorization Biosimilar User Fee Act (BsUFA) reauthorization Biologics Price Competition and Innovation Act (BPCIA) implementation issues Biopharmaceutical and medical innovation policy issues Drug development ecosystem policy issues Drug cost and pricing policy issues Expedited drug approval policy issues Compassionate use policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Transparency policy issues NIH Funding policy issues Precision Medicine Initiative Biomarker policy issues Policy issues related to prescription drug abuse and secure disposal Drug compounding policy issues Prescription drug importation policy issues Cancer Moonshot Prescription drug take back policy issues Clinical trial policy issues Pediatric cancer policy issues Cancer drug vial size policy issues House Republican Health Proposal (A Better Way) Expanded access policy issues

Client expense: $4,990,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

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

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

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

H.R. 6, 21st Century Cures Act (Upton) - new cures and treatments H.R. 34, 21st Century Cures Act (Upton) - medical innovation, mental health, health information technology, telehealth, opioid funding, privacy H.R. 636, Federal Aviation Administration Reauthorization Act (Tiberi) - air ambulance amendments H.R. 691, Telehealth Modernization Act (Matsui-Johnson) - telemedicine H.R. 1189, Preserving Employee Wellness Programs Act (Kline) - employee wellness programs H.R. 2300, Empowering Patients First Act (Price) - health reform issues H.R. 2646, Helping Families in Mental Health Crisis Act (Murphy) - compliance with parity requirements, mental health services H.R. 2712, Commonsense Reporting and Verification Act (Black) - employer reporting and eligibility verification for ACA subsidies H.R. 2745, Standard Merger and Acquisition Reviews Through Equal Rules Act (Farenthold) - FTC-DOJ rules for reviewing mergers H.R. 3099, RAISE Family Caregivers Act (Harper) - national strategy to support family caregivers H.R. 3463, Aligning Childrens Dental Coverage Act (Griffith-DeGette) - rules for stand-alone dental plans H.R. 4276, Behavioral Health Coverage Transparency Act (Kennedy) - disclosure requirements relating to mental health parity H.R. 4641, Best Practices for Pain Management (Brooks) - HHS Task Force to review, revise, and disseminate best practices for pain management H.R. 4771, HEALTH Act (Franks) - medical liability reforms H.R. 5284, World's Greatest Healthcare Plan Act (Sessions) - health reform issues Patient Choice, Affordability, Responsibility, and Empowerment Act (Burr-Hatch-Upton) - health reform issues S. 185, Promise for Antibiotics and Therapeutics for Health Act (Hatch) - FDA drug approval process S. 466, Quality Care for Moms and Babies Act (Stabenow) - pediatric quality measures S. 620, Preserving Employee Wellness Programs Act (Alexander) - employee wellness programs S. 961, Data Security Act (Carper) - data security S. 1077, Advancing Breakthrough Devices for Patients Act (Burr) - priority review of breakthrough medical devices S. 1427, Quality Measure Alignment Act (Stabenow) - facilitating coordination and alignment between public and private sectors on quality and efficiency measures S. 1719, RAISE Family Caregivers Act (Collins) - national strategy to support family caregivers S. 1996, Commonsense Reporting Act (Warner) - employer reporting and eligibility verification for ACA subsidies S. 2141, TRUST IT Act, (Cassidy) - health IT rating system S. 2646, Veterans Choice Improvement Act (Burr) - veterans health care S. 2680, Mental Health Reform Act (Alexander) - compliance with parity requirements, mental health services S. 2700, FDA and NIH Workforce Authorities Modernization Act (Alexander) - medical innovation amendments S. 2985, World's Greatest Healthcare Plan Act (Cassidy) - health reform issues S. 3244, Aligning Children's Dental Coverage Act (Roberts-Bennett) - rules for stand-alone dental plans Regulatory Issues: HIPAA administrative simplification issues, including standards for privacy, security, and electronic transactions and code sets (including ICD-10), identifiers including the health plan identifier, enforcement; cybersecurity; FEHBP enrollment data clearinghouse initiative, the enrollment reconciliation process, and a related OPM reimbursement factor for records that cannot be reconciled; issues relating to health insurance plan participation in FEHBP, including contract requirements; issues relating to similarly sized subscriber group (SSSG) and MLR requirements under the FEHBP; implementation of the health savings account provisions of the Medicare Act; issues related to Medicare Secondary Payer requirements; issues related to implementation of the National Health Information Infrastructure; electronic health records, personal health records, and similar technologies; issues relating to market consolidation; issues related to hospital consolidation; issues relating to quality improvement; issues related to potential priority research topics for the effective health care program; issues relating to the national health data stewardship; issues relating to hospital outpatient measurement and reporting; prescription drug pricing; issues relating to "meaningful use" requirements for health information technology; issues related to the collection of race and ethnicity data; issues related to medical loss ratios; reference pricing; review of rates for reasonableness; preexisting condition insurance plans; issues relating to antitrust; accountable care organizations; provider non-discrimination; coverage of preventive services; contraceptive coverage; pre-existing condition exclusions; lifetime and annual dollar limits on benefits; patient protections; grandfathered health plan provisions; issues relating to the annual fee on health insurance providers; health plan automatic enrollment requirements; issues related to qualified health plans including certification and rate filing templates; health insurance market rules; reinsurance, risk corridors, and risk adjustment (commonly referred to as the 3 Rs); dependent coverage; summary of benefits and coverage disclosures; benefit and payment parameters; essential health benefits, actuarial value, and accreditation; issues related to fraud, waste, abuse, Stark/Anti-Kickback laws and regulations; issues related to supplemental products; issues related to HIPAA excepted benefits; issues related to the federally-facilitated marketplaces (i.e., Exchanges/formerly referred to as the web portal); issues related to business continuity in relation to pandemics or natural events (e.g., hurricane, tornado, etc.); issues related to small employer group size; issues related to Certificate of Public Advantage; and other issues relating to health care reform implementation.

Client expense: $1,330,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Office of Personnel Management (OPM), SENATE, Treasury, Dept of, White House Office

FY2017 Labor-HHS Appropriations hr 5926/s3040 FY2017 FDA-Agriculture Appropriations S. 185, PATH Act S. 1878 Advancing Hope Act of 2016 (pediatric disease PRV extension) H.R. 1850/S. 2782 Ensuring Children's Access to Specialty Care

Client expense: $180,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

21st Century Cures Initiative, drug pricing issues, the Promises for Antibiotics and Therapeutics for Health Act (S.185), proposals to create limited use pathways for certain drugs, CMS reimbursement.

Client expense: $550,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Communications Commission (FCC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), Office of Science & Technology Policy (OSTP), SENATE, Securities & Exchange Commission (SEC), Treasury, Dept of, White House Office

Legislation and policies relating to: Provisions of the Patient Protection & Affordable Care Act (P.L. 111-148) Section 2706 of the ACA regarding provider non-discrimination Policies affecting nurse practitioner education and workforce Definition of essential health benefits and provider network adequacy Health information technology and electronic health records Telehealth provisions of draft medical innovation legislation Mental health services and violence prevention Lead contamination of drinking water H.R. 6/H.R. 34 - 21st Century Cures Act H.R. 30 - Save American Workers Act H.R. 248/S. 305 - American Job Protection Act H.R. 512 - Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act H.R. 596 - To repeal the Patient Protection and Affordable Care Act and health care-related provisions in the Health Care and Education Reconciliation Act of 2010 H.R. 609/S. 287 - Safe Food Act H.R. 879 - Ax the Tax on Middle Class Americans' Health Plans Act H.R. 897 - Zika Vector Control Act H.R. 931 - Helping Effective Antibiotics Last (HEAL) Act H.R. 932/S. 497 - Healthy Families Act H.R. 933/S. 486 - Head Start on Vaccinations Act H.R. 1151 - USPSTF Transparency and Accountability Act of 2015 H.R 1189/S. 620 - Preserving Employee Wellness Programs Act H.R. 1209/S. 628 - Improving Access to Maternity Care Act H.R. 1372 - Home Visiting Extension Act H.R. 1462/S. 799 - Protecting Our Infants Act H.R 1517 - Stop Selling and Marketing to Our Kids E-Cigarettes (SMOKE) Act H.R. 1552 - Preservation of Antibiotics for Medical Treatment Act H.R. 1599 - Safe and Accurate Food Labeling Act H.R 1624 - Protecting Affordable Coverage for Employees (PACE) Act H.R. 2017/S. 2217 - Common Sense Nutrition Disclosure Act H.R. 2300/S. 2519 - Empowering Patients First Act of 2015 H.R. 2646 - Helping Families in Mental Health Crisis Act H.R. 2653 - American Health Care Reform Act H.R. 2690 - Including Families in Mental Health Recovery Act H.R. 2713 - Title VIII Nursing Workforce Reauthorization Act H.R. 2948 - Medicare Telehealth Parity Act H.R. 3081/S. 1778 - Telemedicine for Medicare (TELE-MED) Act H.R. 3299 - Strengthening Public Health Emergency Response Act of 2015 H.R. 3379 - Airplane Kits Act H.R. 3463 - Aligning Childrens Dental Coverage Act H.R. 3495 - Women's Public Health and Safety Act H.R. 3660 - Preventive Health Savings Act H.R. 3659 - Exchange Inclusion for a Healthy America Act H.R. 3762 - Restoring Americans Healthcare Freedom Reconciliation Act H.R. 3865/S. 2542 - Cradle Act H.R. 4276 - Behavioral Health Coverage Transparency Act H.R. 4400/S. 2512 - Adding Zika Virus to the FDA Priority Review Voucher Program Act H.R. 4479 - Families of Flint Act H.R. 4723 - Protecting Taxpayers by Recovering Improper Obamacare Subsidy Overpayments Act H.R. 4724 - Reducing Duplicative and Ineffective Federal Funding Act H.R. 4771 - Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2016 H.R. 5001/S. 2822 - Flexibility in Health IT Reporting (Flex-IT) Act H.R. 5003 - Improving Child Nutrition and Education Act of 2016 H.R. 5065/S. 3299 - Bottles and Breastfeeding Equipment Screening (BABES) Act H.R. 5284 - Worlds Greatest Healthcare Plan Act of 2016 H.R. 5456/S. 3065 - Family First Prevention Services Act S. 30 - Forty Hours Is Full Time Act S. 142/H.R. 1375/H.R. 3242 - Child Nicotine Poisoning Prevention Act S. 185 - Promise for Antibiotics and Therapeutics for Health (PATH) Act S. 203 - American Liberty Restoration Act S. 339 - ObamaCare Repeal Act S. 481 - Improving Regulatory Transparency for New Medical Therapies Act S. 522 - Protecting & Retaining Our Children's Health Insurance Program (PRO-CHIP) Act S. 612 - Water Infrastructure Improvements for the Nation Act S. 621 - Prevention of Antibiotic Resistance Act S. 673 - Winding Down Obamacare Act S. 674 - 21st Century Womens Health Act S. 764 - National Bioengineered Food Disclosure Standard S. 971 - Medicare Independence at Home Medical Practice Demonstration Improvement Act S. 993/H.R. 1854 - Comprehensive Justice and Mental Health Act S. 1014 - Personal Care Products Safety Act S. 1016 - Preserving Freedom and Choice in Health Care Act S. 1456 - Rural ACO Improvement Act S. 1549 - Care Planning Act S. 1793 - Promoting Physical Activity for Americans Act S. 1893 - Mental Health Awareness and Improvement Act S. 1945 - Mental Health Reform Act S. 2002/H.R. 3722 - Mental Health and Safe Communities Act S. 2045/H.R. 2050 - Middle Class Health Benefits Tax Repeal Act S. 2075 - American Worker Health Care Tax Relief Act S. 2100 - Tobacco to 21 Act S. 2153 - Provider Payment Sunshine Act S. 2173/H.R. 3712 - Improving Access to Mental Health Act S. 2218/H.R. 1218 - Personal Health Investment (PHIT) Act S. 2259 - ACO Assignment Improvement Act S. 2261 - Rural ACO Provider Equity Act S. 2343/H.R. 4155 - Telehealth Innovation and Improvement Act S. 2380 - Public Health Emergency Response and Accountability Act S. 2408/H.R. 4266 - Nurse and Health Care Worker Protection Act S. 2484 - Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act S. 2525/H.R. 4567 - Expand Excellence in Mental Health Act of 2016 S. 2609 - An original bill to amend the Agricultural Marketing Act of 1946 to require the Secretary of Agriculture to establish a national voluntary labeling standard for bioengineered foods S. 2680 - Mental Health Reform Act of 2016 S. 2687 - Plan of Safe Care Improvement Act S. 2821 - Testing, Removal, and Updated Evaluations of Lead Everywhere in America for Dramatic Enhancements that Restore Safety to Homes, Infrastructure, and Pipes (True LEADership) Act of 2016 S. 2848/H.R. 5303 - Water Resources Development Act of 2016 S. 2873/H.R. 5395 - Expanding Capacity for Health Outcomes (ECHO) Act S. 3136 - Improving Child Nutrition Integrity and Access Act of 2016 S. 3190 - Strengthening Our Rural Health Workforce Act of 2016 S. 3239 - Research to Accelerate Cures and Equity (RACE) for Children Act S. 3245 - Nursing Workforce Reauthorization Act of 2016 S. 3504 - Creating High-Quality Results and Outcomes Necessary to Improve Chronic (CHRONIC) Care Act

Client expense: Not reported · Firm income: $23,450

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA), White House Office

HR 5426/S 3042, Justice for Servicemembers Act of 2016; GI Bill Eligibility - 100% Post-9/11 GI Bill Eligibility for all Purple Heart Recipients; Military Health Care, generally and TriCARE provisions contained in the 2017 NDAA Bill; GI Bill - Financial Protections and Services for GI Bill Beneficiaries; 2017 MilCon Appropriations, provisions for in-Vitro fertilization programs for veterans; S. 3328 Employment Rights of Public Health Service Officers; S. 185, Promise for Antibiotics and Therapeutics for Health Act (PATH Act); HR 34; 21st Century Cures Act - Provisions to include PATH Act Language HR 358, Purple Heart Commemorative Coin Act; HR 250, Families of Fallen Servicemembers First Act; HR 6272, VA Provider Pay Modernization Act; HR 6273, VA Healthcare Provider Education Debt Relief Act; HR 6416, Jeff Miller and Richard Blumenthal Veterans Health Care and Improvement Act of 2016 - Sec. 401 Fry Scholarship provisions; HR 3476/6377, National Guard Bonus Repayment and Financial Relief Act; HR 6234, Private Corrado Piccoli Purple Heart Preservation Act of 2016;

Client expense: $40,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Justice, Dept of (DOJ), SENATE, Veterans Affairs, Dept of (VA), White House Office

Issues related to S. 2689 Reliable and Effective Growth for Regenerative Health Options that Improve Wellness (REGROW) Act Issues related to S. 185 Promise for Antibiotics and Therapeutics for Health (PATH) Act Issues related to H.R. 6463 Patient Safety Toxicology Modernization Act

Client expense: $50,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

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

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

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

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

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

P.L. 114-255 - 21st Century Cures Act - Issues focused on preventing opioid abuse. H.R. 5327 Continuing Resolution for Appropriations and Military Construction, VA and Related Agencies Act of 2017 and Zika Response and Preparedness Act - issues related to opioid issues, policies focused on antibiotic resistance and other public health related policies. S. 524 - The Comprehensive Addiction and Recovery Act - supporting efforts to fight opioid abuse in the United States. Work focused on the inclusion of "lock in" programs in the Medicare program to prevent and protect seniors from opioid addiction. S.185 - The Promise for Antibiotics and Therapeutics for Health (PATH) Act - Focused on ensuring that the Food and Drug Administration has the necessary to tools to ensure that medically needed antibiotics are made available to the public. S. 2153 - Provider Payment Sunshine Act - policies supporting the inclusion of all prescribers to the Open Payments program. H.R. 5054 - Agriculture Appropriations Bill for FY 2017 - Issues related to FDA treatment of antibiotics and compounding of certain pharmaceuticals. Legislative and regulatory issues surrounding unique device identifiers (UDI) being addressed by CMS, FDA and ONC. Advancing provisions to highlight Antibiotic Innovation and combating prescription drug abuse in the President's FY 2017 budget. Supporting policies to maintain the integrity of laws regarding compounding of certain medications. Issues related to ending prescription drug abuse and diversion in Medicare and Medicaid.

Client expense: Not reported · Firm income: $25,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

P.L. 114-255 - 21st Century Cures Act - Issues focused on preventing opioid abuse. H.R. 5327 Continuing Resolution for Appropriations and Military Construction, VA and Related Agencies Act of 2017 and Zika Response and Preparedness Act - issues related to opioid issues, policies focused on antibiotic resistance and other public health related policies. S. 1549 - The Care Planning Act - supporting advances in End-of-Life Care throughout the nation. S. 524 - The Comprehensive Addiction and Recovery Act - supporting efforts to fight opioid abuse in the United States. Work focused on the inclusion of "lock in" programs in the Medicare program to prevent and protect seniors from opioid addiction. S.185 - The Promise for Antibiotics and Therapeutics for Health (PATH) Act - Focused on ensuring that the Food and Drug Administration has the necessary to tools to ensure that medically needed antibiotics are made available to the public. S. 2153 - Provider Payment Sunshine Act - policies supporting the inclusion of all prescribers to the Open Payments program. H.R. 5054 - Agriculture Appropriations Bill for FY 2017 - Issues related to FDA treatment of antibiotics and compounding of certain pharmaceuticals. Legislative and regulatory issues surrounding unique device identifiers (UDI) being addressed by CMS, FDA and ONC. Exploring new policies to improve end of life care in America.

Client expense: Not reported · Firm income: $25,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

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

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

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

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

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

S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 289: American Cures Act - Provisions related to National Institutes of Health (NIH) funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 524: Comprehensive Addiction and Recovery Act of 2016 - Provisions related to opioids S. 1077: Advancing Breakthrough Devices for Patients Act of 2016 - Issues related to the biopharmaceutical industry S. 1597: Patient-Focused Impact Assessment Act of 2016 - Provisions related to patient-focused drug development S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: Combination Product Regulatory Fairness Act of 2016 - Provisions related to improvements in the regulation of combination drug-device products S. 1878: Advancing Hope Act of 2016 - Provisions related to pediatric cancer and other pediatric diseases S.2055: Medical Countermeasure Innovation Act of 2015 S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act - Provisions related to priority review vouchers S. 2615: Increasing Competition in Pharmaceuticals Act - Provisions related to FDA review of generic drugs and study on risk evaluation and mitigation strategies (REMS) program S. 2680: Mental Health Reform Act of 2016 - Provisions related to mental health issues S. 2689: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments S. 2700: FDA and NIH Workforce Modernization Act - Provisions related to FDA and NIH S. 2912: Trickett Wendler Right to Try Act of 2016 - A bill to authorize the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law, and for other purposes - Provisions related to use of unapproved medical products by patients with a terminal illness S. 3056: CREATES Act of 2016 - Provisions related to access to samples of prescription drugs S. 3239: RACE for Children Act - Provisions related to pediatric studies S. 3335: Fair Accountability and Innovative Research (FAIR) Drug Pricing Act - Provisions relating to transparency H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 1538: Compassionate Access, Research Expansion, and Respect States (CARERS) Act of 2015 - Provisions related to regulation of marijuana and impact on medical research H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2805: Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 - Provisions related to the treatment of heroin and prescription opioid abuse H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 or FAST Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing H.R. 3012: Right to Try Act of 2015 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 3250: DXM Abuse Prevention Act of 2015 H.R. 3299: The Strengthening Public Health Emergency Response Act of 2015 H.R. 3381: Childhood Cancer STAR Act - Provisions related to expanded access and other issues H.R. 4762: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments H.R. 4784: Lower Drug Costs Through Competition Act - Provisions related to generic drugs and priority review vouchers; REMS study; and tropical disease product applications H.R. 5046: Comprehensive Opioid Abuse Reduction Act of 2016 - Provisions related to opioids H.R. 5122: A bill to prohibit further action on the proposed rule regarding testing of Medicare Part B prescription drug models H.R. 5858: The RACE for Children Act - Provisions related to pediatric studies H.R. 6043: Fair Accountability and Innovative Research (FAIR) Drug Pricing Act of 2016 - Provisions related to transparency H.R. 6174: Closing Loopholes for Orphan Drugs Act - Provisions relating to 340B discounts on orphan drugs Other: - Kids Innovative Drugs Act (draft) - Incentives for the development of pediatric oncology drugs - The Regenerative Medicine Regulatory Improvement Act (discussion draft) - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments - Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development - Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) - Incentives for the development of pediatric drugs - Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues - Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures - Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy - Proposed HRSA 340B program mega-guidance - Provisions related to 340B program - Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges - 340B Drug Discount Program policy issues - General FDA advocacy including sharing of truthful and non-misleading information about medicines with healthcare professionals - Prescription Drug User Fee Act (PDUFA) reauthorization - Biosimilar User Fee Act (BsUFA) reauthorization - Biologics Price Competition and Innovation Act (BPCIA) implementation issues - Biopharmaceutical and medical innovation policy issues - Drug development ecosystem policy issues - Drug cost and pricing policy issues - Expedited drug approval policy issues - Compassionate use policy issues - Biosimilar approval and reimbursement policy issues - Transparency policy issues - NIH Funding policy issues - Precision Medicine Initiative - Biomarker policy issues - Policy issues related to prescription drug abuse and secure disposal - Drug compounding policy issues - Prescription drug importation policy issues - Cancer Moonshot - Prescription drug take back policy issues - Clinical trial policy issues - Pediatric cancer policy issues - Cancer drug vial size policy issues - House Republican Health Proposal (A Better Way) - OTC Monograph Reform - Expanded access policy issues - Patient assistance program policy issues

Client expense: $640,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), Vice President of the U.S.

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

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

Interoperability and Regulation of Health IT, including the SOFTWARE Act (H.R. 2396), MEDTECH Act (S. 1101), Improving Heath Information Technology Act (S. 3511), and 21st Century Cures Act (H.R. 6). Food and Drug Administration: drug, medical device, and agency reforms including improving scientific capacity at FDA and use of public-private partnerships (FDA and NIH Workforce Authorities Modernization Act, S. 2700); use of real-world evidence and drug development tools such as biomarkers and patient-reported outcomes (21st Century Cures Act, H.R. 6); and the approval process for certain items such as antibiotics (e.g., PATH Act, S. 185), treatments for unmet needs (e.g., Dormant Therapies Act of 2014, S. 3004, 113th Congress), combination products (e.g., S. 1767), and regenerative medicine/cellular therapies (REGROW Act, S. 2689/H.R. 4762). Medicare, including chronic care coordination, prevention, and health care delivery and payment reform Long-term care financing and Medicaid Money Follows the Person Rebalancing Demonstration program reauthorization Beneficiaries dually eligible for Medicare and Medicaid

Client expense: $260,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Budget and appropriations for disease and injury prevention, including obesity and related diseases; pandemic influenza and emerging infectious diseases; physical activity; public health bioterrorism preparedness; food safety, environmental health; paid sick days; womens and childrens health; community-based public health interventions and prescription drug abuse. Specific Legislation: 1.Implementation of the Patient Protection and Affordable Care Act (Public Law 111-148) 2.Implementation of the FDA Food Safety Modernization Act (Public Law 111-353) 3.Implementation of Pandemic and All-Hazards Preparedness Reauthorization Act (Public Law 113-5) 4.Implementation of Healthy, Hunger-Free Kids Act of 2010 (Public Law 111-296) 5.Implementation of the Budget Control Act of 2011 (Public Law 112-25) 6.Implementation of the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (Public Law 113-5) 7.Implementation of the Drug Quality and Security Act of 2013 (Public Law 113-54) 8.Implementation of Animal Drug and Animal Generic Drug User Fee Act (Public Law 113-14) 9.Implementation of Child Care and Development Block Grant Act of 2014 (Public Law 113-186) 10.Promoting Health as Youth Skills in Classrooms and Life Act (S. 418) 11.National Diabetes Clinical Care Commission Act (H.R. 1192/S. 586) 12.Energy Consumers Relief Act (S. 156) 13.FIT Kids Act (S. 1075/H.R. 2013) 14.Climate Change Health Protection and Promotion Act (H.R. 1275) 15.Treat and Reduce Obesity Act (S. 1509/H.R. 2404) 16.A bill to amend the Congressional Budget Act of 1974 respecting the scoring of preventive health savings (H.R. 3660) 17.Developing a Reliable and Innovation Vision for the Economy (DRIVE) Act (S. 1647) 18.Summer Meals Act of 2014 (S. 613/H.R. 1728) 19.Long-Term SCORE Act (H.R. 282/S. 2260) 20.American Cures Act (S. 289) 21.School Food Modernization Act (S. 540) 22.Protecting Children from Electronic Cigarette Advertising Act of 2014 (S. 430/H.R. 478) 23.Bicycle and Pedestrian Infrastructure Improvement Act of 2015 (H.R. 199) 24.Waters of the United States Regulatory Overreach Protection Act of 2014 (H.R. 594) 25.Promise for Antibiotics and Therapeutics for Health Act (PATH Act, S. 185) 26.Helping Effective Antibiotics Last (HEAL) Act (H.R. 931) 27.Safe Food Act of 2015 (H.R. 609/S. 287) 28.21st Century Cures Act (H.R. 6) 29.Preservation of Antibiotics for Medical Treatment Act (H.R. 1552) 30.Preventing Antibiotic Resistance Act (S. 621) 31.Healthy Families Act (H.R. 932/S. 497) 32.Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act (H.R. 512) 33.Antibiotic Development to Advance Patient Treatment Act (not yet introduced) 34.Recognizing the importance of vaccinations and immunizations in the United States (H.Res. 117) 35.Good Samaritan Health Professionals Act (H.R. 865/S. 3101) 36.Head Start on Vaccinations Act (H.R. 933/S. 486) 37.Opioid Overdose Reduction Act (S. 707/H.R. 1821) 38.Comprehensive Addiction and Recovery Act (S. 524/H.R. 953) 39.CHIP Extension and Improvement Act of 2015 (S. 522/H.R. 919) 40.Secret Science Reform Act of 2015 (S. 544/H.R. 1030) 41.EPA Science Advisory Board Reform Act of 2015 (S. 543/H.R. 1029) 42.Medicare Access and CHIP Reauthorization Act of 2015 (H.R. 2) 43.Student Success Act (H.R. 5) 44.Every Child Achieves Act (S. 1177) 45.Sugar-Sweetened Beverages Tax (SWEET) Act (H.R. 1687) 46.Transportation Alternatives Program Improvement Act (S. 705) 47.Jason Simcakoski Memorial Opioid Safety Act (S. 1641/H.R. 4063) 48.Recovery Enhancement for Treatment (TREAT) Act (S. 1455/H.R. 2536) 49.FDA Deeming Authority Clarification Act (H.R. 2058) 50.Pathogen Reduction and Testing Reform Act (H.R. 2303) 51.Medicare Diabetes Prevention Act (S. 1131/H.R. 2102) 52.Ratepayer Protection Act (H.R. 2042) 53.Affordable Reliable Electricity Now Act (S. 1324) 54.Protecting Seniors Access to Medicare Act (H.R. 1190/S. 141) 55.Family Asthma Act (S. 1064) 56.School Asthma Management Plan Act (S. 1065) 57.Healthy Relationships Act (H.R. 453/S. 923) 58.Healthy School Meals Flexibility Act (S. 1146/H.R. 2508) 59.Reducing Federal Mandates on School Lunch Act (H.R. 1504) 60.Safe Streets Act (H.R. 2071) 61.Healthy Kids Outdoors (S. 1078/H.R. 2014) 62.Highway and Transportation Funding Act (H.R. 2353) 63.Federal Water Quality Protection Act (S. 1140) 64.Friendly Airports for Mothers Act (H.R. 2530) 65.Overdose Prevention Act (S. 2092/H.R. 4288) 66.Stop Overdose Stat Act (H.R. 2850) 67.Stop Child Summer Hunger Act (S. 1539/H.R. 2715) 68.Promoting Physical Activity for Americans Act (S. 1793/H.R. 1499) 69.Defund Planned Parenthood Act of 2015 (H.R. 3134) 70.Continuing Appropriations Act, 2016 (H.R. 719) 71.Strengthening Public Health Emergency Response Act (H.R. 3299) 72.Consolidated Appropriations Act, 2016 (Public Law 114-113) 73.Restoring Americans Healthcare Freedom Reconciliation Act of 2015 (H.R. 3762/Senate Amendment) 74.A joint resolution providing for congressional disapproval under chapter 8 of title 5, United States Code, of the rule submitted by the Corps of Engineers and the Environmental Protection Agency relating to the definition of "waters of the United States" under the Federal Water Pollution Control Act (S.J. Res 22) 75.A joint resolution providing for congressional disapproval under chapter 8 of title 5, United States Code, of a rule submitted by the Environmental Protection Agency relating to "Standards of Performance for Greenhouse Gas Emissions from New, Modified, and Reconstructed Stationary Sources: Electric Utility Generating Units" (S.J.Res. 23) 76.On the Joint Resolution: S.J.Res. 24; A joint resolution providing for congressional disapproval under chapter 8 of title 5, United States Code, of a rule submitted by the Environmental Protection Agency relating to "Carbon Pollution Emission Guidelines for Existing Stationary Sources: Electric Utility Generating Units" (S.J.Res 24) 77.Common Sense Nutrition Disclosure Act (H.R. 2017/S. 2217) 78.Food Labeling Modernization Act (H.R. 4061/S. 2301) 79.Fixing Americas Surface Transportation Act (Public Law 114-93) 80.Every Student Succeeds Act (Public Law 114-95) 81.Puerto Rico Assistance Act, 2015 (S. 2381) 82.Full-Service Community Schools Act, 2015 (S. 1787) 83.FY2017 Commerce, Justice, State Appropriations Act (no bill number) 84.FY2017 Financial Services and General Government Appropriations Act (no bill number) 85.Energy Policy Modernization Act of 2015 (S. 2012) 86.Hallways to Health Act (S. 2590/H.R. 4621) 87.GET THE LEAD OUT Act of 2016 (S. 2588) 88.CLEAR Act (S. 2587) 89.TEST KIDS Act (S. 2586) 90.FUND Water Act (S. 2583) 91.NURSE Act (S. 2572) 92.A joint resolution providing for congressional disapproval under chapter 8 of title 5, United States Code, of the rule submitted by the Corps of Engineers and the Environmental Protection Agency relating to the definition of "waters of the United States" under the Federal Water Pollution Control Act. (S.J.Res.22) 93.The Ozone Standards Implementation Act of 2016 (H.R. 4775) 94.Ozone National Ambient Air Quality Standard Deadline Harmonization Act of 2015 (H.R. 4000) 95.To repeal the Prevention and Public Health Fund (H.R. 1085) 96.Common Sense Savings Act of 2016 (H.R. 4725) 97.Establishing the congressional budget for the United States Government for fiscal year 2017 and setting forth the appropriate budgetary levels for fiscal years 2018 through 2026 (H.Con.Res. 125) 98.Improving Child Nutrition Integrity and Access Act of 2016 (S. 3136) 99.Promoting Biomedical Research and Public Health for Patients Act (S. 2742) 100.Preventing Superbugs and Protecting Patients Act (S. 2503) 101.The Medical Countermeasures Innovation Act (S. 2055) 102.FY2016 emergency supplemental appropriations request for Zika preparedness and response (no bill number) 103.FY2016 Labor, Health and Human Services, and Education Appropriations Act (S. 1695/H.R. 3020) 104.FY2016 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act (S. 1800/H.R. 3049/S. 2129) 105.FY 2016 Financial Services and General Government Appropriations bill, in support of an appropriation for the National Alliance for Model State Drug Laws (H.R. 2995/S. 1910/S. 2132) 106.FY2016 Congressional Budget Resolution (S.Con.Res. 11/H.Con.Res 27) 107.FY2016 Homeland Security Appropriations Act (S. 1619/H.R. 3128/S.2131) 108.FY2017 Military Construction-VA Appropriations and Zika Supplemental (H.R. 2577) 109.Public Health Emergency Preparedness Act (H.R. 4525) 110.PREPARE Act (H.R. 3583) 111.Zika Response Appropriations Act (H.R. 5243) 112.Making Supplemental Appropriations for fiscal year 2016 to respond to Zika virus (H.R. 5044) 113.A bill to provide emergency supplemental appropriations to address the Zika crisis (S. 2843) 114.FY 2017 Departments of Labor, Health and Human Services, and Education and Related Agencies Appropriations Act (S. 3040) 115.FY 2017 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act (S. 2956/H.R. 5054) 116.Health Equity and Accountability Act of 2016 (H.R. 5475) 117.SMASH Act (S. 3039) 118.Improving Child Nutrition and Education Act (H.R. 5003) 119.Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2017, and Zika Response and Preparedness Act (H.R. 5325) 120.Interior, Environment and Related Agencies Appropriations Bill, 2017 121.Ozone Standards Implementation Act (S. 2882) 122.National Defense Authorization Act for Fiscal Year 2017 (S. 2943) 123.Environmental Health Workforce Act of 2016 (H.R. 5543)

Client expense: $40,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Education, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Federal Emergency Management Agency (FEMA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Housing & Urban Development, Dept of (HUD), Office of Management & Budget (OMB), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), Transportation, Dept of (DOT)

H.R. 6, 21st Century Cures Act (Upton) - new cures and treatments H.R. 636, Federal Aviation Administration Reauthorization Act (Tiberi) - air ambulance amendments H.R. 691, Telehealth Modernization Act (Matsui-Johnson) - telemedicine H.R. 1189, Preserving Employee Wellness Programs Act (Kline) - employee wellness programs H.R. 2646, Helping Families in Mental Health Crisis Act (Murphy) - compliance with parity requirements, mental health services H.R. 2712, Commonsense Reporting and Verification Act (Black) - employer reporting and eligibility verification for ACA subsidies H.R. 2745, Standard Merger and Acquisition Reviews Through Equal Rules Act (Farenthold) - FTC-DOJ rules for reviewing mergers H.R. 3099, RAISE Family Caregivers Act (Harper) - national strategy to support family caregivers H.R. 3463, Aligning Childrens Dental Coverage Act (Griffith-DeGette) - rules for stand-alone dental plans H.R. 4276, Behavioral Health Coverage Transparency Act (Kennedy) - disclosure requirements relating to mental health parity H.R. 4641, Best Practices for Pain Management (Brooks) - HHS Task Force to review, revise, and disseminate best practices for pain management H.R. 4771, HEALTH Act (Franks) - medical liability reforms H.R. 5054, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies (Aderholt) - 21st Century Cures provisions S. 185, Promise for Antibiotics and Therapeutics for Health Act (Hatch) - FDA drug approval process S. 466, Quality Care for Moms and Babies Act (Stabenow) - pediatric quality measures S. 524, Comprehensive Addiction and Recovery Act (Whitehouse) - prescription opioid abuse S. 620, Preserving Employee Wellness Programs Act (Alexander) - employee wellness programs S. 961, Data Security Act (Carper) - data security S. 1077, Advancing Breakthrough Devices for Patients Act (Burr) - priority review of breakthrough medical devices S. 1427, Quality Measure Alignment Act (Stabenow) - facilitating coordination and alignment between public and private sectors on quality and efficiency measures S. 1719, RAISE Family Caregivers Act (Collins) - national strategy to support family caregivers S. 1996, Commonsense Reporting Act (Warner) - employer reporting and eligibility verification for ACA subsidies S. 2141, TRUST IT Act, (Cassidy) - health IT rating system S. 2646, Veterans Choice Improvement Act (Burr) - veterans health care S. 2680, Mental Health Reform Act (Alexander) - compliance with parity requirements, mental health services S. 2700, FDA and NIH Workforce Authorities Modernization Act (Alexander) - medical innovation amendments S. 3040, Labor, Health and Human Services, and Education Appropriations Act for fiscal year 2017 (Blunt) - funding for HHS programs and agencies, ACA risk corridors program S. 3244, Aligning Children's Dental Coverage Act (Roberts-Bennett) - rules for stand-alone dental plans Regulatory Issues: HIPAA administrative simplification issues, including standards for privacy, security, and electronic transactions and code sets (including ICD-10), identifiers including the health plan identifier, enforcement; cybersecurity; FEHBP enrollment data clearinghouse initiative, the enrollment reconciliation process, and a related OPM reimbursement factor for records that cannot be reconciled; issues relating to health insurance plan participation in FEHBP, including contract requirements; issues relating to similarly sized subscriber group (SSSG) and MLR requirements under the FEHBP; implementation of the health savings account provisions of the Medicare Act; issues related to Medicare Secondary Payer requirements; issues related to implementation of the National Health Information Infrastructure; electronic health records, personal health records, and similar technologies; issues relating to market consolidation; issues related to hospital consolidation; issues relating to quality improvement; issues related to potential priority research topics for the effective health care program; issues relating to the national health data stewardship; issues relating to hospital outpatient measurement and reporting; prescription drug pricing; issues relating to "meaningful use" requirements for health information technology; issues related to the collection of race and ethnicity data; issues related to medical loss ratios; reference pricing; review of rates for reasonableness; preexisting condition insurance plans; issues relating to antitrust; accountable care organizations; provider non-discrimination; coverage of preventive services; contraceptive coverage; pre-existing condition exclusions; lifetime and annual dollar limits on benefits; patient protections; grandfathered health plan provisions; issues relating to the annual fee on health insurance providers; health plan automatic enrollment requirements; issues related to qualified health plans including certification and rate filing templates; health insurance market rules; reinsurance, risk corridors, and risk adjustment (commonly referred to as the 3 Rs); dependent coverage; summary of benefits and coverage disclosures; benefit and payment parameters; essential health benefits, actuarial value, and accreditation; issues related to fraud, waste, abuse, Stark/Anti-Kickback laws and regulations; issues related to supplemental products; issues related to HIPAA excepted benefits; issues related to the federally-facilitated marketplaces (i.e., Exchanges/formerly referred to as the web portal); issues related to business continuity in relation to pandemics or natural events (e.g., hurricane, tornado, etc.); issues related to small employer group size; issues related to Certificate of Public Advantage; and other issues relating to health care reform implementation.

Client expense: $1,710,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), SENATE, Treasury, Dept of, White House Office

Infectious diseases (generally, no specific legislation); drug, diagnostics and vaccine R&D (generally, no specific legislation); antimicrobial resistance (generally, no specific legislation); antimicrobial stewardship (generally, no specific legislation); hospital-acquired infections (generally, no specific legislation); immunizations (generally, no specific legislation); pandemic influenza, public health security and biodefense (generally, no specific legislation); global infectious diseases (generally, no specific legislation); biomedical research (generally, no specific legislation); reauthorization of the President's Emergency Plan for AIDS Relief (PEPFAR) (generally, no specific legislation); Lyme diseases and other infectious diseases issues (generally, no specific legislation); Ryan White reauthorization (generally, no specific legislation); Prescription Drug User Fee Act (PDUFA)(generally, no specific legislation); Antibiotic Development to Advance Patient Treatment (ADAPT) Act (HR 2629); Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act (HR 512); Promise for Antibiotics and Therapeutics for Health (PATH) Act (S.185); Preventing Antibiotic Resistance Act (PARA)(S.621)

Client expense: $160,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Natl Institutes of Health (NIH), SENATE

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

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

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

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

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)

Legislation and policies relating to: Provisions of the Patient Protection & Affordable Care Act (P.L. 111-148) Section 2706 of the ACA regarding provider non-discrimination Policies affecting nurse practitioner education and workforce Definition of essential health benefits and provider network adequacy Health information technology and electronic health records Telehealth provisions of draft medical innovation legislation Mental health services and violence prevention Lead contamination of drinking water H.R. 6 - 21st Century Cures Act H.R. 30 - Save American Workers Act H.R. 248/S. 305 - American Job Protection Act H.R. 512 - Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act H.R. 596 - To repeal the Patient Protection and Affordable Care Act and health care-related provisions in the Health Care and Education Reconciliation Act of 2010 H.R. 609/S. 287 - Safe Food Act H.R. 879 - Ax the Tax on Middle Class Americans' Health Plans Act H.R. 897 - Zika Vector Control Act H.R. 931 - Helping Effective Antibiotics Last (HEAL) Act H.R. 932/S. 497 - Healthy Families Act H.R. 933/S. 486 - Head Start on Vaccinations Act H.R 1189/S. 620 - Preserving Employee Wellness Programs Act H.R. 1209/S. 628 - Improving Access to Maternity Care Act H.R. 1372 - Home Visiting Extension Act H.R. 1462/S. 799 - Protecting Our Infants Act H.R 1517 - Stop Selling and Marketing to Our Kids E-Cigarettes (SMOKE) Act H.R. 1552 - Preservation of Antibiotics for Medical Treatment Act H.R. 1599 - Safe and Accurate Food Labeling Act H.R 1624 - Protecting Affordable Coverage for Employees (PACE) Act H.R. 2017/S. 2217 - Common Sense Nutrition Disclosure Act H.R. 2300/S. 2519 - Empowering Patients First Act of 2015 H.R. 2646 - Helping Families in Mental Health Crisis Act H.R. 2653 - American Health Care Reform Act H.R. 2690 - Including Families in Mental Health Recovery Act H.R. 2713 - Title VIII Nursing Workforce Reauthorization Act H.R. 2948 - Medicare Telehealth Parity Act H.R. 3081/S. 1778 - Telemedicine for Medicare (TELE-MED) Act H.R. 3299 - Strengthening Public Health Emergency Response Act of 2015 H.R. 3379 - Airplane Kits Act H.R. 3463 - Aligning Childrens Dental Coverage Act H.R. 3495 - Women's Public Health and Safety Act H.R. 3660 - Preventive Health Savings Act H.R. 3659 - Exchange Inclusion for a Healthy America Act H.R. 3762 - Restoring Americans Healthcare Freedom Reconciliation Act H.R. 3865/S. 2542 - Cradle Act H.R. 4276 - Behavioral Health Coverage Transparency Act H.R. 4400/S. 2512 - Adding Zika Virus to the FDA Priority Review Voucher Program Act H.R. 4479 - Families of Flint Act H.R. 4723 - Protecting Taxpayers by Recovering Improper Obamacare Subsidy Overpayments Act H.R. 4724 - Reducing Duplicative and Ineffective Federal Funding Act H.R. 4771 - Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2016 H.R. 5001/S. 2822 - Flexibility in Health IT Reporting (Flex-IT) Act H.R. 5003 - Improving Child Nutrition and Education Act of 2016 H.R. 5284 - Worlds Greatest Healthcare Plan Act of 2016 H.R. 5456/S. 3065 - Family First Prevention Services Act S. 30 - Forty Hours Is Full Time Act S. 142/H.R. 1375/H.R. 3242 - Child Nicotine Poisoning Prevention Act S. 185 - Promise for Antibiotics and Therapeutics for Health (PATH) Act S. 203 - American Liberty Restoration Act S. 339 - ObamaCare Repeal Act S. 481 - Improving Regulatory Transparency for New Medical Therapies Act S. 522 - Protecting & Retaining Our Children's Health Insurance Program (PRO-CHIP) Act S. 621 - Prevention of Antibiotic Resistance Act S. 673 - Winding Down Obamacare Act S. 674 - 21st Century Womens Health Act S. 764 - National Bioengineered Food Disclosure Standard S. 971 - Medicare Independence at Home Medical Practice Demonstration Improvement Act S. 993/H.R. 1854 - Comprehensive Justice and Mental Health Act S. 1014 - Personal Care Products Safety Act S. 1016 - Preserving Freedom and Choice in Health Care Act S. 1456 - Rural ACO Improvement Act S. 1549 - Care Planning Act S. 1793 - Promoting Physical Activity for Americans Act S. 1893 - Mental Health Awareness and Improvement Act S. 1945 - Mental Health Reform Act S. 2002/H.R. 3722 - Mental Health and Safe Communities Act S. 2045/H.R. 2050 - Middle Class Health Benefits Tax Repeal Act S. 2075 - American Worker Health Care Tax Relief Act S. 2100 - Tobacco to 21 Act S. 2153 - Provider Payment Sunshine Act S. 2173/H.R. 3712 - Improving Access to Mental Health Act S. 2218/H.R. 1218 - Personal Health Investment (PHIT) Act S. 2259 - ACO Assignment Improvement Act S. 2261 - Rural ACO Provider Equity Act S. 2343/H.R. 4155 - Telehealth Innovation and Improvement Act S. 2380 - Public Health Emergency Response and Accountability Act S. 2408/H.R. 4266 - Nurse and Health Care Worker Protection Act S. 2484 - Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act S. 2525/H.R. 4567 - Expand Excellence in Mental Health Act of 2016 S. 2609 - An original bill to amend the Agricultural Marketing Act of 1946 to require the Secretary of Agriculture to establish a national voluntary labeling standard for bioengineered foods S. 2680 - Mental Health Reform Act of 2016 S. 2687 - Plan of Safe Care Improvement Act S. 2821 - Testing, Removal, and Updated Evaluations of Lead Everywhere in America for Dramatic Enhancements that Restore Safety to Homes, Infrastructure, and Pipes (True LEADership) Act of 2016 S. 2848/H.R. 5303 - Water Resources Development Act of 2016 S. 3190 - Strengthening Our Rural Health Workforce Act of 2016 S. 3239 - Research to Accelerate Cures and Equity (RACE) for Children Act S. 3245 - Nursing Workforce Reauthorization Act of 2016

Client expense: Not reported · Firm income: $23,450

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA), White House Office

S.185, PATH Act (issues related to 21st Century cures and antibiotic regulation) Issues related to antibiotic resistance and hospital infections Issues related to dietary supplement safety Issues related to off label promotion of drugs and devices Issues related to opioid addiction treatment drug prices Issues related to patient safety Issues related to prescription drug and EpiPen prices Issues related to surprise medical bills Issues related to informed consent Issues related to health insurance mergers

Client expense: $40,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Consumer Financial Protection Bureau (CFPB), Consumer Product Safety Commission (CPSC), Education, Dept of, Environmental Protection Agency (EPA), Federal Communications Commission (FCC), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Natl Highway Traffic Safety Administration (NHTSA), Natl Telecommunications & Information Administration (NTIA), Office of Management & Budget (OMB), Office of the Comptroller of the Currency (OCC), SENATE, White House Office

S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 289: American Cures Act - Provisions related to National Institutes of Health (NIH) funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 524: Comprehensive Addiction and Recovery Act of 2016 - Provisions related to opioids S. 1077: Advancing Breakthrough Devices for Patients Act of 2016 - Issues related to the biopharmaceutical industry S. 1597: Patient-Focused Impact Assessment Act of 2016 - Provisions related to patient-focused drug development S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: Combination Product Regulatory Fairness Act of 2016 - Provisions related to improvements in the regulation of combination drug-device products S. 1878: Advancing Hope Act of 2016 - Provisions related to pediatric cancer and other pediatric diseases S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act - Provisions related to priority review vouchers S. 2615: Increasing Competition in Pharmaceuticals Act - Provisions related to FDA review of generic drugs and study on risk evaluation and mitigation strategies (REMS) program S. 2680: Mental Health Reform Act of 2016 - Provisions related to mental health issues S. 2689: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments S. 2700: FDA and NIH Workforce Modernization Act - Provisions related to FDA and NIH S. 2912: Trickett Wendler Right to Try Act of 2016 - A bill to authorize the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law, and for other purposes - Provisions related to use of unapproved medical products by patients with a terminal illness S. 3056: CREATES Act of 2016 - Provisions related to access to samples of prescription drugs S. 3239: RACE for Children Act - Provisions related to pediatric studies S. 3335: Fair Accountability and Innovative Research (FAIR) Drug Pricing Act - Provisions relating to transparency H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 1538: Compassionate Access, Research Expansion, and Respect States (CARERS) Act of 2015 - Provisions related to regulation of marijuana and impact on medical research H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2805: Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 - Provisions related to the treatment of heroin and prescription opioid abuse H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 or FAST Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing H.R. 3012: Right to Try Act of 2015 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 3381: Childhood Cancer STAR Act - Provisions related to expanded access and other issues H.R. 4762: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments H.R. 4784: Lower Drug Costs Through Competition Act - Provisions related to generic drugs and priority review vouchers; REMS study; and tropical disease product applications H.R. 5046: Comprehensive Opioid Abuse Reduction Act of 2016 - Provisions related to opioids H.R. 5122: A bill to prohibit further action on the proposed rule regarding testing of Medicare Part B prescription drug models H.R. 5858: The RACE for Children Act - Provisions related to pediatric studies H.R. 6043: Fair Accountability and Innovative Research (FAIR) Drug Pricing Act of 2016 - Provisions related to transparency H.R. 6174: Closing Loopholes for Orphan Drugs Act - Provisions relating to 340B discounts on orphan drugs Kids Innovative Drugs Act (draft) - Incentives for the development of pediatric oncology drugs The Regenerative Medicine Regulatory Improvement Act (discussion draft) - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) - Incentives for the development of pediatric drugs Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Proposed HRSA 340B program mega-guidance - Provisions related to 340B program Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges 340B Drug Discount Program policy issues General FDA advocacy including sharing of truthful and non-misleading information about medicines with healthcare professionals Prescription Drug User Fee Act (PDUFA) reauthorization Biosimilar User Fee Act (BsUFA) reauthorization Biologics Price Competition and Innovation Act (BPCIA) implementation issues Biopharmaceutical and medical innovation policy issues Drug development ecosystem policy issues Drug cost and pricing policy issues Expedited drug approval policy issues Compassionate use policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Transparency policy issues NIH Funding policy issues Precision Medicine Initiative Biomarker policy issues Policy issues related to prescription drug abuse and secure disposal Drug compounding policy issues Prescription drug importation policy issues Cancer Moonshot Prescription drug take back policy issues Clinical trial policy issues Pediatric cancer policy issues Cancer drug vial size policy issues House Republican Health Proposal (A Better Way) Expanded access policy issues

Client expense: $4,130,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

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: $10,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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 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

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.

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

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.

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

Issues related to S. 2689 Reliable and Effective Growth for Regenerative Health Options that Improve Wellness (REGROW) Act Issues related to S. 185 Promise for Antibiotics and Therapeutics for Health (PATH) Act

Client expense: $50,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

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

FY2017 Labor-HHS Appropriations hr 5926/s3040 FY2017 FDA-Agriculture Appropriations S. 185, PATH Act S. 1878 Advancing Hope Act of 2016 (pediatric disease PRV extension) H.R. 1850/S. 2782 Ensuring Children's Access to Specialty Care

Client expense: $180,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE