Advancing Breakthrough Devices for Patients Act of 2016

H.R. 6 21st Century Cures Act Innovation for Healthier Americans House and Senate Agriculture Appropriations bills S. 1077, The Advancing Breakthrough Medical Devices for Patients Act of 2015 S.1622, FDA Device Accountability Act of 2015 S.2737, Improving Medical Device Innovation Act Issues related to lab developed tests H.R. 5403, To amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting devices. proposals related to Medicare Parts A & B

Client expense: Not reported · Firm income: $30,000

Government targets: 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

PL 111-148 - The Patient Protection and Affordable Care Act, implementation PL 112-144 - The Food and Drug Administration Safety and Innovation Act, implementation H.R. 3204 - The Drug Quality and Security Act, implementation H.R. 6 - 21st Century Cures H.R. 3762 - Restoring Americans' Healthcare Freedom Reconciliation Act of 2015 Innovation For Healthier Americans H.R. 34 - 21st Century Cures Act ***, no specific bill(s), import safety, health care reform, 510K reform, medical device user fee program, companion diagnostics, user fee sequester S. 1077 - Advancing Breakthrough Medical Devices for Patients Act S. 1101 - Medical Electronic Data Technology Enhancement for Consumers Health Act S. 1767 - Combination Products Innovation Act S. 2700 - FDA and NIH Workforce Authorities Modernization Act S. 1101 - MEDTECH Act S. 1622 - FDA Device Accountability Act of 2015 S. 2737 - Improving Medical Device Innovation Act

Client expense: Not reported · Firm income: $70,000

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

H.R. 6 21st Century Cures Act Innovation for Healthier Americans House and Senate Agriculture Appropriations bills S. 1077, The Advancing Breakthrough Medical Devices for Patients Act of 2015 S.1622, FDA Device Accountability Act of 2015 S.2737, Improving Medical Device Innovation Act Issues related to lab developed tests H.R. 5403, To amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting devices.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Seeking to maintain or increase protection for the public with reference to psychiatric treatments including drugs and brain devices in H. R. 6 - 21st Century Cures Act, in H. R. 34 - An Act To accelerate the discovery, development, and delivery of 21st century cures, and for other purposes, in House Appropriations Subcommittee Bill on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies for FY 2017 (containing provisions of H. R. 6), in H. R. 2646 - Helping Families in Mental Health Crisis, in S. 1077 - Advancing Breakthrough Devices For Patients Act of 2015, in S. 2680 - Mental Health Reform Act of 2016 and in FDA Proposed Rule on Electroconvulsive Therapy (ECT).

Client expense: Not reported · Firm income: $20,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Seeking to maintain or increase protection for the public with reference to psychiatric treatments including drugs and brain devices in H. R. 6 - 21st Century Cures Act, in H. R. 2646 - Helping Families in Mental Health Crisis and in S. 1077 - Advancing Breakthrough Devices For Patients Act of 2015. Opposition to FDA Proposed Rule on electroconvulsive therapy (ECT) devices.

Client expense: Not reported · Firm income: $30,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Seeking to maintain or increase protection for the public with reference to psychiatric treatments including drugs and brain devices in H. R. 6 - 21st Century Cures Act, in House Appropriations Subcommittee Bill on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies for FY 2017 (containing provisions of H. R. 6), in H. R. 2646 - Helping Families in Mental Health Crisis in S. 1077 - Advancing Breakthrough Devices For Patients Act of 2015, in S. 2680 - Mental Health Reform Act of 2016 and in FDA Proposed Rule on Electroconvulsive Therapy (ECT).

Client expense: Not reported · Firm income: $30,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Seeking to maintain or increase protection for the public with reference to psychiatric treatments including drugs and brain devices in H. R. 6 - 21st Century Cures Act, in House Appropriations Subcommittee Bill on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies for FY 2017 (containing provisions of H. R. 6), in H. R. 2646 - Helping Families in Mental Health Crisis in S. 1077 - Advancing Breakthrough Devices For Patients Act of 2015, in S. 2680 - Mental Health Reform Act of 2016 and in FDA Proposed Rule on Electroconvulsive Therapy (ECT).

Client expense: Not reported · Firm income: $30,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Seeking to maintain or increase protection for the public with reference to psychiatric treatments including drugs and brain devices in H. R. 6 - 21st Century Cures Act, in H. R. 34 - An Act To accelerate the discovery, development, and delivery of 21st century cures, and for other purposes, in House Appropriations Subcommittee Bill on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies for FY 2017 (containing provisions of H. R. 6), in H. R. 2646 - Helping Families in Mental Health Crisis in S. 1077 - Advancing Breakthrough Devices For Patients Act of 2015, in S. 2680 - Mental Health Reform Act of 2016 and in FDA Proposed Rule on Electroconvulsive Therapy (ECT).

Client expense: Not reported · Firm income: $30,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S 1077 Advancing Breakthrough Devices for Patients S2014 HR3466 Next Generation Researchers Act HR 3731, S 2030 Rare Disease Fund Act of 2015 S 2624 National Biomedical Research Act S 1878 Advancing Hope Act of 2015 S 2055 Medical Countermeasure Innovation Act of 2016 S 1622 FDA Device Accountability Act S 849 Advancing Research for Neurological Diseases Act of 2015 S 800 Enhancing the Stature and Visibility of Medical Rehabilitation Research at the NIH Act S 2713 Advancing Precision Medicine Act of 2016 S 2745 NIH Strategic Plan and Inclusion in Clinical Research S 2472 Promoting Biomedical Research and Public Health for Patients Act (to reduce regulatory burden on NIH-funded researchers) HR 34 21st Century Cures Act (formerly HR 6), signed into law

Client expense: $38,669 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to implementation of PL 112-144, the Food and Drug Administration Safety and Innovation Act Issues related to the use of device registries and legislation to improve the use of clinical data registries Issues related to the regulation and publication of clinical trials for medical devices Issues related to FDA public communications regarding emerging signals Issues related to the regulation of blood glucose meters HR. 6 the "21st Century Cures Act" Issues related to the Medical Device User Fee Agreement Issues related to the competitiveness of the medical technology industry and the impact of Federal policies. Issues related to the regulation of combination products Issues related to FDA inspection of foreign and domestic manufacturing facilities Issues related to diagnostics regulation Issues related to WHO administration of diagnostics access program Issues related to the regulation of mobile medical technology Issues related to promoting innovation in the med tech industry and improving FDA regulating procedures for devices Issues related to cybersecurity for medical technology Issues related to the regulation of transporting lithium batteries for medical devices by air Issues related to credentialing for industry representatives in VA health care facilities Issues related to procurement and acquisition policies of the VA health system for medical technology and supplies Issues related to the regulation of contact lenses Issues related to De-Identified Bio-specimens and Diagnostics Development Issues related to the regulation of and access to cancer diagnostics, imaging, and radiation therapies Issues relating to USDA import policies S.1077 Advancing Breakthrough Devices for Patients Act of 2015 S.1622 FDA Device Accountability Act of 2015 S. 1101 MEDTECH Act S. 2188 The Rare Disease Innovation Act S. 2187 The FDA Regulatory Efficiency Act S. 1767 Combination Product Regulatory Fairness Act S. 2737 the Improving Medical Device Innovation Act H.R. 636/S. 2658 the FAA Re-authorization Act H.R. 5403 Ariel Graces Law H.R. 5404 Medical Device Guardians Act H.R. 3422, the VA Vendor Verification Act

Client expense: $650,000 · 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 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

PL 111-148 - The Patient Protection and Affordable Care Act, implementation PL 112-144 - The Food and Drug Administration Safety and Innovation Act, implementation H.R. 6 - 21st Century Cures Innovation For Healthier Americans H.R. 34 - 21st Century Cures Act ***, no specific bill(s), 510k reform, imaging policy, medical device user fee reauthorization and all related policies, mobile medical apps, device regulation, Innovation S. 1101 - MEDTECH Act S. 1077 - Advancing Breakthrough Medical Devices for Patients Act S. 1101 - Medical Electronic Data Technology Enhancement for Consumers Health Act S. 1767 - Combination Products Innovation Act

Client expense: Not reported · Firm income: $80,000

Government targets: Centers For Medicare and Medicaid Services (CMS), 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 PL 112-144 - The Food and Drug Administration Safety and Innovation Act, implementation H.R. 3204 - The Drug Quality and Security Act, implementation H.R. 6 - 21st Century Cures Innovation For Healthier Americans H.R. 34 - 21st Century Cures Act ***, no specific bills, FDA related issues, diagnostics, drug shortages, compounding, pandemic preparedness, innovation initiative, health IT S. 1077 - Advancing Breakthrough Medical Devices for Patients Act S. 1101 - Medical Electronic Data Technology Enhancement for Consumers Health Act S. 1767 - Combination Products Innovation Act S. 2700 - FDA and NIH Workforce Authorities Modernization Act S. 524/H.R. 953 - Comprehensive Addiction and Recovery Act of 2016

Client expense: Not reported · Firm income: $60,000

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

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

H.R. 3762, Restoring Americans Healthcare Freedom Reconciliation Act H.R. 592/S. 314, Pharmacy and Medically Underserved Areas Enhancement Act H.R. 954, CO-OP Consumer Protection Act of 2016 H.R. 1190/S. 141, The Protecting Seniors Access to Medicare Act of 2015 H.R. 1192, National Clinical Care Commission Act H.R. 1270, Restoring Access to Medication and Improving Health Savings Act H.R. 1427, Medicare CGM Access Act H.R. 1686/S. 3082, Preventing Diabetes in Medicare Act H.R. 1707, Access to Frontline Health Care Act of 2015 H.R. 1726, Access to Quality Diabetes Education Act H.R. 1807, Sickle Cell Disease Research, Surveillance, Prevention, and Treatment Act of 2015 H.R. 2102, Medicare Diabetes Prevention Act H.R. 2124/S. 1148, Resident Physician Shortage Act H.R. 2603/S. 1475, Saving Lives, Saving Costs Act H.R. 2646, Helping Families in Mental Crisis Act H.R. 2713/S. 3245, Title VIII Nursing Workforce Reauthorization Act of 2016 H.R. 3081/S. 1778, Telemedicine for Medicare Act H.R. 3119/S. 2748, Palliative Care and Hospice Education and Training Act H.R. 3660/S. 3126,Preventive Health Savings Act H.R. 3952/S. 2248, Congenital Heart Future Reauthorization Act of 2015 H.R. 4212/S. 704, Community Based Independence for Seniors Act of 2015 H.R. 4442/S. 2484, CONNECT for Health Act H.R. 4732/S. 2671, Advancing Medical Resident Training in Community Hospitals Act H.R. 4774, Training Tomorrows Doctors Today Act H.R. 4909/S. 2943, National Defense Authorization Act H.R. 5273, Helping Hospitals Improve Patient Care Act H.R. 5414, FDA Cross-Center Collaboration Act H.R. 5447/S. 3060, The Small Business Health Care Relief Act H.R. 5652,Access to Better Care Act H.R. 5681/S. 3137, Alzheimers Beneficiary and Caregiver Support Act H.R. 5713, Sustaining Healthcare Integrity and Fair Treatment Act of 2016 H.R.5926 - Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2017 H.R. 6043/S. 3335, The Fair Accountability and Innovative Research Drug Pricing Act of 2016 H.R. 6109/S. 3371, Medicare Affordability and Enrollment Act S. 524, Comprehensive Addiction and Recovery Act S. 586, National Diabetes Clinical Care Commission Act S. 603, Jobs and Premium Protection Act S. 776,Medication Therapy Management Empowerment Act S. 1077,Advancing Breakthrough Medical Devices for Patients Act S. 1101,Medical Electronic Data Technology Enhancement for Consumers Health (MEDTECH) Act S. 1622,FDA Device Accountability Act S. 2511,Improving Health Information Technology Act S. 2680,Mental Health Reform Act of 2016 S. 2864,Reducing Existing Costs Associated with Pharmaceuticals for Seniors Act of 2016 S. 3326,State Flexibility to Provide Affordable Health Options Act S. 3504, Creating High-Quality Results and Outcomes Necessary to Improve Chronic (CHRONIC) Care Act of 2016 Pub. L. 111-5, The American Recovery and Reinvestment Act of 2009 (Health Information Technology for Economic and Clinical Health Act (HITECH) Pub. L. 111-148, Patient Protection and Affordable Care Act (PPACA) Pub. L. 114-10, Medicare Access and CHIP Reauthorization Act (MACRA) Pub. L. 114-255,21st Century Cures Pub. L. 114-270, Expanding Capacity for Health Outcomes Act (ECHO) Pub. L. 114-328, National Defense Authorization Act for Fiscal Year 2017

Client expense: $150,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

H.R. 1190/S. 141, The Protecting Seniors Access to Medicare Act of 2015 H.R. 1270, Restoring Access to Medication and Improving Health Savings Act H.R. 1427, Medicare CGM Access Act H.R. 1686/S. 3082, Preventing Diabetes in Medicare Act H.R. 1707, Access to Frontline Health Care Act of 2015 H.R. 1726, Access to Quality Diabetes Education Act H.R. 2102, Medicare Diabetes Prevention Act H.R. 2124/S. 1148, Resident Physician Shortage Act H.R. 2603/S. 1475, Saving Lives, Saving Costs Act H.R. 3119/S. 2748, Palliative Care and Hospice Education and Training Act H.R. 3660/S. 3126,Preventive Health Savings Act H.R. 3952/S. 2248, Congenital Heart Future Reauthorization Act of 2015 H.R. 4212/S. 704, Community Based Independence for Seniors Act of 2015 H.R. 5273, Helping Hospitals Improve Patient Care Act H.R. 5681/S. 3137, Alzheimers Beneficiary and Caregiver Support Act H.R.5926 - Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2017 H.R. 6043/S. 3335, The Fair Accountability and Innovative Research Drug Pricing Act of 2016 H.R. 6109/S. 3371, Medicare Affordability and Enrollment Act S. 776,Medication Therapy Management Empowerment Act S. 1077,Advancing Breakthrough Medical Devices for Patients Act S. 1101,Medical Electronic Data Technology Enhancement for Consumers Health (MEDTECH) Act S. 2864,Reducing Existing Costs Associated with Pharmaceuticals for Seniors Act of 2016 S. 3326,State Flexibility to Provide Affordable Health Options Act Pub. L. 111-5, The American Recovery and Reinvestment Act of 2009 (Health Information Technology for Economic and Clinical Health Act (HITECH) Pub. L. 114-10, Medicare Access and CHIP Reauthorization Act (MACRA) Pub. L. 114-255,21st Century Cures

Client expense: $150,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

- Issues related to promoting competitiveness of the medical technology industry and the impact of federal policies. - H.R. 160, (Protect Medical Innovation Act), S. 149 (Medical Device Access and Innovation Protection Act)and provisions related to repeal of the medical device excise tax. - S.1077 Advancing Breakthrough Devices for Patients Act of 2015, provisions relating to breakthrough pathway.

Client expense: $70,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 6 21st Century Cures Act Innovation for Healthier Americans House and Senate Agriculture Appropriations bills S. 1077, The Advancing Breakthrough Medical Devices for Patients Act of 2015 S.1622, FDA Device Accountability Act of 2015 S.2737, Improving Medical Device Innovation Act Issues related to lab developed tests H.R. 5403, To amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting devices. proposals related to Medicare Parts A & B

Client expense: Not reported · Firm income: $30,000

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

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

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

H.R. 6 21st Century Cures Act Innovation for Healthier Americans House and Senate Agriculture Appropriations bills S. 1077, The Advancing Breakthrough Medical Devices for Patients Act of 2015 S.1622, FDA Device Accountability Act of 2015 S.2737, Improving Medical Device Innovation Act Issues related to lab developed tests H.R. 5403, To amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting devices. proposals related to Medicare Parts A & B

Client expense: Not reported · Firm income: Not reported

H.R. 6 21st Century Cures Act Innovation for Healthier Americans House and Senate Agriculture Appropriations bills S. 1077, The Advancing Breakthrough Medical Devices for Patients Act of 2015 S.1622, FDA Device Accountability Act of 2015 S.2737, Improving Medical Device Innovation Act Issues related to lab developed tests H.R. 5403, To amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting devices. proposals related to Medicare Parts A & B

Client expense: Not reported · Firm income: Not reported

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)

HR 6 21st Century Cures S 1077 Advancing Breakthrough Devices for Patients S2014 HR3466 Next Generation Researchers Act HR 3731, S 2030 Rare Disease Fund Act of 2015 S 2624 National Biomedical Research Act S 1878 Advancing Hope Act of 2015 S 2055 Medical Countermeasure Innovation Act of 2016 S 1622 FDA Device Accountability Act S 849 Advancing Research for Neurological Diseases Act of 2015 S 800 Enhancing the Stature and Visibility of Medical Rehabilitation Research at the NIH Act S 2713 Advancing Precision Medicine Act of 2016 S 2745 NIH Strategic Plan and Inclusion in Clinical Research S 2472 Promoting Biomedical Research and Public Health for Patients Act (to reduce regulatory burden on NIH-funded researchers)

Client expense: $58,768 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 6, the 21st Century Cures Act, specifically those sections relating to regulatory and reimbursement policies affecting the medical technology industry. H.R. 1078, the Food and Drug Administration Safety Over Sequestration Act. H.R. 160, the Protect Medical Innovation Act. S. 149, the Medical Device Access and Innovation Protection Act. S. 1077, the Advancing Breakthrough Devices for Patients Act. S. 1622, the FDA Device Accountability Act. S. 2737, the Improving Medical Device Innovation Act. Public Law No. 112-144, the Food and Drug Administration Safety and Innovation Act, specifically those sections relating to implementation of the Medical Device User Fee program. Public Law No. 111-148, the Patient Protection and Affordable Care Act, specifically implementation issues regarding the medical device tax, accountable care organizations and the Sunshine Act.

Client expense: Not reported · Firm income: $60,000

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. 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)

Issues related to implementation of PL 112-144, the Food and Drug Administration Safety and Innovation Act Issues related to the use of device registries and legislation to improve the use of clinical data registries HR. 6 the "21st Century Cures Act" Issues related to the Medical Device User Fee Agreement Issues related to the competitiveness of the medical technology industry and the impact of Federal policies. Issues related to the regulation of combination products Issues related to diagnostics regulation Issues related to WHO administration of diagnostics access program Issues related to the regulation of mobile medical technology Issues related to promoting innovation in the med tech industry and improving FDA regulating procedures for devices Issues related to cybersecurity for medical technology Issues related to the regulation of transporting lithium batteries for medical devices by air Issues related to credentialing for industry representatives in VA health care facilities Issues related to procurement and acquisition policies of the VA health system for medical technology and supplies Issues related to the regulation of contact lenses Issues related to De-Identified Bio-specimens and Diagnostics Development Issues related to the regulation of and access to cancer diagnostics, imaging, and radiation therapies Issues relating to USDA import policies S.1077 Advancing Breakthrough Devices for Patients Act of 2015 S.1622 FDA Device Accountability Act of 2015 S. 1101 MEDTECH Act S. 2188 The Rare Disease Innovation Act S. 2187 The FDA Regulatory Efficiency Act S. 1767 Combination Product Regulatory Fairness Act S. 2737 the Improving Medical Device Innovation Act H.R. 636/S. 2658 the FAA Re-authorization Act H.R. 5403 Ariel Graces Law H.R. 5404 Medical Device Guardians Act H.R. 3422, the VA Vendor Verification Act

Client expense: $700,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Monitor 21st Century Cures Legislation, HR 6. Consolidated and Further Continuing Appropriations Act, 2015 HR 83 S. 1878, The Advancing Hope Act of 2015 S. 1077, The Advancing Breakthrough Medical Devices for Patients Act of 2015 S. 1101, The Medical Electronic Data Technology Enhancement for Consumers Health Act S. 2055, The Medical Countermeasures Innovation Act of 2015 S. 1767, The Combination Products Innovation Act of 2015 S. 1597, Patient Focused Impact Assessment Act of 2015

Client expense: Not reported · Firm income: $20,000

Government targets: Administration for Children & Families (ACF), 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

PL 111-148 - The Patient Protection and Affordable Care Act, implementation PL 112-144 - The Food and Drug Administration Safety and Innovation Act, implementation H.R. 6 - 21st Century Cures Innovation For Healthier Americans ***, no specific bill(s), 510k reform, imaging policy, medical device user fee reauthorization and all related policies, mobile medical apps, device regulation, Innovation S. 1101 - MEDTECH Act S. 1077 - Advancing Breakthrough Medical Devices for Patients Act S. 1101 - Medical Electronic Data Technology Enhancement for Consumers Health Act S. 1767 - Combination Products Innovation Act

Client expense: Not reported · Firm income: $80,000

Government targets: Centers For Medicare and Medicaid Services (CMS), 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

PL 111-148 - The Patient Protection and Affordable Care Act, implementation PL 112-144 - The Food and Drug Administration Safety and Innovation Act, implementation H.R. 3204 - The Drug Quality and Security Act, implementation H.R. 6 - 21st Century Cures Innovation For Healthier Americans ***, no specific bills, FDA related issues, diagnostics, drug shortages, compounding, pandemic preparedness, innovation initiative, health IT S. 1077 - Advancing Breakthrough Medical Devices for Patients Act S. 1101 - Medical Electronic Data Technology Enhancement for Consumers Health Act S. 1767 - Combination Products Innovation Act S. 2700 - FDA and NIH Workforce Authorities Modernization Act S. 524/H.R. 953 - Comprehensive Addiction and Recovery Act of 2016

Client expense: Not reported · Firm income: $60,000

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

PL 111-148 - The Patient Protection and Affordable Care Act, implementation PL 112-144 - The Food and Drug Administration Safety and Innovation Act, implementation H.R. 3204 - The Drug Quality and Security Act, implementation H.R. 6 - 21st Century Cures H.R. 3762 - Restoring Americans' Healthcare Freedom Reconciliation Act of 2015 Innovation For Healthier Americans ***, no specific bill(s), import safety, health care reform, 510K reform, medical device user fee program, companion diagnostics, user fee sequester S. 1077 - Advancing Breakthrough Medical Devices for Patients Act S. 1101 - Medical Electronic Data Technology Enhancement for Consumers Health Act S. 1767 - Combination Products Innovation Act S. 2700 - FDA and NIH Workforce Authorities Modernization Act S. 1101 - MEDTECH Act S. 1622 - FDA Device Accountability Act of 2015 S. 2737 - Improving Medical Device Innovation Act

Client expense: Not reported · Firm income: $70,000

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Seeking to maintain or increase protection for the public with reference to psychiatric treatments including drugs and brain devices in H. R. 6 - 21st Century Cures Act, in House Appropriations Subcommittee Bill on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies for FY 2017 (containing provisions of H. R. 6), in H. R. 2646 - Helping Families in Mental Health Crisis, in S. 1077 - Advancing Breakthrough Devices For Patients Act of 2015, in S. 2680 - Mental Health Reform Act of 2016 and in FDA Proposed Rule on Electroconvulsive Therapy (ECT).

Client expense: Not reported · Firm income: $20,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE