Fair Accountability and Innovative Research Drug Pricing Act of 2016

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)

S. 3040, H.R. 5926, H.R. 5325,H.R. 2028, Labor, Health and Human Services Appropriations, FY2017 - Lobbied for funding support for various health and health care related programs serving seniors. S.3111, Seniors Tax Hike Prevention Act - Discussed medical expense deduction for the 65 plus population. Advocated on the issue of limited age rating for private health insurance. S. 3335, H.R. 6043, FAIR Drug Pricing Act - Supported bill. Discussed the Confidence in Long-Term Care Insurance Act (S. 159)/Long-Term Care Insurance Reform Act (H.R. 63) (bill numbers are in the 112th Congress). Discussed ACA repeal, Medicare, and Medicaid.

Client expense: $2,530,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Equal Employment Opportunity Commission (EEOC), Federal Transit Administration (FTA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Pension Benefit Guaranty Corporation (PBGC), SENATE, Securities & Exchange Commission (SEC), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

H.R.6 - Discussed the House Energy and Commerce Committee 21st Century Cures Initiative and Senate HELP Committee efforts focused on drug and medical device innovation issues. S. 31, H.R. 3061 - Discussed the importance of potential savings to both consumers and the federal government of granting Secretarial negotiating authority to the HHS Secretary under Medicare Part D. S. 2019 - Discussed legislation to address pay-for-delay agreements used by drug manufacturers to block lower cost drugs from entering the market. S. 3094, H.R. 5573 - Discussed legislation to reduce the market exclusivity period for biologic drugs. Discussed biologic drug issues including implementation of the new approval pathway for biosimilar drugs. S. 3335, H.R. 6043 - Discussed the need for price transparency on prescription drug prices and comparativeness effectiveness research. Discussed legislation to address the opioid abuse epidemic including fraud and abuse provisions. Discussed opioid issues generally. S. 3056 - Discussed legislation to address abuse of Risk-Evaluation and Mitigation Strategies (REMS) by brand name drug companies to block lower-cost generic drugs from entering the market. S. 3455 - Discussed legislation to allow temporary importation authority in cases of drug shortages and non-competitive markets. S. 2956, H.R. 5054, H.R. 5325, H.R. 2028, Agriculture Appropriations, FY2017 - Lobbied in support of FDA funding. H.R. 6043, FAIR Drug Pricing Act - Supported bill to require manufactures of certain drugs and biological products to report to HHS price increases that result in a 10% or more increase in the price of a drug over a 12 month period.

Client expense: $2,530,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Equal Employment Opportunity Commission (EEOC), Federal Transit Administration (FTA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Pension Benefit Guaranty Corporation (PBGC), SENATE, Securities & Exchange Commission (SEC), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

H.R. 9, Innovation Act (Goodlatte) - changes to inter partes review process H.R. 1600, Patients' Access to Treatments Act (McKinley-Capps) - specialty drug tiers H.R. 4599, Reducing Unused Medications Act (Clark) - partial fillings of prescriptions H.R. 4784, Lower Drug Costs Through Competition Act (Schrader-Bilirakis) - prescription drug issues H.R. 5122, Medicare Part B Prescription Drug Demonstration (Bucshon) H.R. 5951, Improving Transparency and Accuracy in Medicare Part D Spending Act (Griffith) - Medicare Part D pharmacy payments H.R. 6043, Fair Accountability and Innovative Research Drug Pricing Act (Schakowsky) - reporting requirements for prescription drug price increases S. 1137, PATENT Act (Grassley) - changes to inter partes review process S. 2019, Preserve Access to Affordable Generics Act (Klobuchar-Grassley) - pay-for-delay settlements S. 2023, Prescription Drug Affordability Act (Sanders) - pharmaceutical issues S. 2578, Reducing Unused Medications Act (Warren) - partial fillings of prescriptions S. 2615, Increasing Competition in Pharmaceuticals Act (Collins-McCaskill) - prescription drug issues S. 2689, REGROW Act (Kirk) - stem cell /regenerative medicines S. 3056, CREATES Act (Leahy) - challenging anti-competitive practices of brand name drug manufacturers S. 3308, Improving Transparency and Accuracy in Medicare Part D Spending Act (Capito) - Medicare Part D pharmacy payments S. 3335, Fair Accountability and Innovative Research Drug Pricing Act (Baldwin) - reporting requirements for prescription drug price increases Regulatory Issues: Issues relating to long term safety and effectiveness of medical devices and drugs, including registries; issues relating to post-market surveillance of drugs and medical devices; issues relating to price of drugs and biologics; issues relating to access for investigational drugs; 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

H.R. 6, H.R. 34 & Public Law 114-255, 21st Century Cures Act; S. 2700, FDA and NIH Workforce Authorities Modernization Act; H.R. 3381, Childhood Cancer STAR Act; Discussions to clarify or reform the 340B program; Biologics Price Competition and Innovation Act; Public Law 111-148, The Patient Protection and Affordable Care Act; Public Law 111-152, The Health Care and Education Reconciliation Act; H.R. 2228 & S.122, Safe and Affordable Drugs from Canada Act of 2015; Proposals to address prescription drug abuse; Implementation/Reauthorization of The Prescription Drug User Fee Act (PDUFA); Implementation/Reauthorization of The Biosimilars User Fee Act (BsUFA); H.R. 639 & S. 481, Improving Regulatory Transparency for New Medical Therapies; H.R. 2570 & S. 1396, Value-Based Insurance Design Seniors Copayment Reduction Act of 2015; H.R. 3012 & S. 2912, Trickett Wendler Right to Try Act of 2016; H.R. 6043 & S. 3335, Fair Accountability and Innovative Research Drug Pricing Act of 2016; S.3239, RACE for Children Act; Expanded Access (legislation not introduced) H.R. 4207, Medicare Fair Drug Pricing Act of 2015; Clinton's 1993 Health Security Act; S. 2023, Prescription Drug Affordability Act of 2015; H.R. 6501, Prescription Drug and Medical Device Price Review Board Act of 2016; S.3455, Pharmaceutical Supply and Value Enhancement Act; Repeal and Replace Proposals for Public Law 111-148, The Patient Protection and Affordable Care Act (no legislation introduced);

Client expense: $1,040,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health Resources & Services Administration (HRSA), Medicare Payment Advisory Commission (MedPAC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

Labor, Health and Human Services, Education, and Related Agencies Appropriations Bill, regarding all biopharmaceutical related provisions. Agriculture Appropriations, regarding all biopharmaceutical related provisions. H.R. 1078, FDA Safety Over Sequestration Act, regarding all biopharmaceutical related provisions. No bill, raised awareness about atrial fibrillation and stroke prevention. H/R. 1101, Viral Hepatitis Testing Act, regarding all biopharmaceutical related provisions. H.R.6 and H.R. 34, 21st Century Cures Initiative and Senate Innovation for a Healthier America proposal, regarding all biopharmaceutical related provisions. No Bill, lobbied Congress on biosimilar issues including naming, labeling and interchangeability. No Bill, lobbied Congress on importation of prescription drugs. S. 2912, Trickett Wendler Right to Try Act of 2016, S. 2912, regarding all biopharmaceutical related provisions. S. 3056, Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2016, regarding all biopharmaceutical related provisions. No Bill, Prescription Drug User Fee Act, regarding all biopharmaceutical related provisions. No Bill, Biosimilar User Fee Act, regarding all biopharmaceutical related provisions. S. 3335/H.R. 6043 the Fair Accountability and Innovative Research Drug Pricing Act, regarding all biopharmaceutical related provisions.

Client expense: $560,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Trade Representative (USTR)

IMPACT Act implementation; Accountable Care Organizations/Medicare Shared Savings Program; Pay for Value/Delivery System Reform; Post-acute care/skilled nursing facilities access; Home Health Care payment rates; Prescription drug costs and pricing; Alternative Payment models including bundling; Medicare Access and CHIP reauthorization Act (MACRA) implementation; Center for Medicare and Medicaid Services Technical Expert Panel nominations; home health pre-claim review demonstration; Section 1115 Waivers; H.R. 3298 the Medicare Post-Acute Care Value-Based Purchasing Act of 2015; H.R. 6043 Fair Drug Pricing Act of 2015; Protecting Access to Medicare Act Implementation.

Client expense: $240,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

P.L. 111-148 Patient Protection and Affordable Care Act: Employer responsibility requirements insurance coverage expansions P.L. 111-152 Health Care and Education Reconciliation Act of 2010: Employer responsibility requirements insurance coverage expansions H.R.2050/S. 2045 Middle Class Health Benefits Tax Repeal Act of 2015: Provisions repealing the tax on high cost health care plans H.R.2712/S. 1996 Commonsense Reporting and Verification Act of 2015: Provisions reducing employers' requirements to report compliance with the ACA employer responsibility requirement S. 2698: Preserving Consumer Health Accounts Act of 2016: Provisions that exempt health savings accounts and flexible spending arrangements from excise tax on high cost health plans S. 2499/H.R. 4469: Health Savings Act of 2016: Provisions that permit expanded use of Health S. 1809, H.R. 863 (STARS Act): Provisions affecting definition of seasonal employment for purposes of ACA employer responsibility S. 3056: CREATES Act of 2016, provisions that limit misuse of drug safety protocols H.R. 879: Ax the Tax on Middle Class Americans' health plans Act: Provisions repealing the tax on high cost health care plans H.R. 1270: Restoring access to medication and improving health savings act of 2016: provisions H.R. 210: Student worker exemption act: provisions H.R. 5573: PRICED Act: provisions H.R. 5410: Health Coverage state flexibility act of 2016: provisions H.R. 5589: Plan verification & fairness act of 2016: provisions HR 4832: Health Savings Protection Act: Provisions that exempt health savings accounts and flexible spending arrangements from excise tax on high cost health plans Legislation to increase the allowed variation in exchange plan premiums based on age: provisions EBSA Miscellaneous regulatory Affordable Care Act repeal replace: analysis ACA implementation S. 3335/HR 6043: Fair Accountability and Innovative Research Drug Pricing Act of 2016: provisions to require manufacturer transparency in setting prices for pharmaceutical drugs

Client expense: $540,000 · Firm income: Not reported

Government targets: Defense, Dept of (DOD), Export-Import Bank of the United States (EXIM Bank), HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Labor Relations Board (NLRB), Occupational Safety & Health Administration (OSHA), SENATE, Securities & Exchange Commission (SEC), Social Security Administration (SSA), State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR)

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

IMPACT Act implementation; Accountable Care Organizations/Medicare Shared Savings Program; Pay for Value/Delivery System Reform; Post-acute care/skilled nursing facilities access; Home Health Care payment rates; Prescription drug costs and pricing; Alternative payment models including bundling; Medicare Access and CHIP reauthorization Act (MACRA) implementation; Center for Medicare and Medicaid Services Technical Expert Panel nominations; home health pre-claim review demonstration; Section 1115 Waivers; H.R. 3298 the Medicare Post-Acute Care Value-Based Purchasing Act of 2015; H.R. 6043 Fair Drug Pricing Act of 2015; Protecting Access to Medicare Act implementation.

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

S.2615: Increasing Competition in Pharmaceuticals Act, support increasing generic availability. H.R.6/P.L. 114-252: The 21st Century Cures Act and Senate companions, ensuring no new barriers to generic and biosimilar market entry. Generic Drug User Fee Act Reauthorization, support increasing generic availability. H.R.1600: The Patients' Access to Treatment Act, educating on the importance of step therapy to ensuring optimal therapy access and cost control. H.R.2841: the FAST Generics Act. S.3056: the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act. Drug pricing in general. H.R.6043 and S.3335, "Fair Accountability and Innovative Research Drug Pricing Act of 2016".

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicare Part B Premium. (No bill.) Proposals to mitigate the expected increase in the 2017 Part B premium for beneficiaries not protected by the "hold harmless" provision. Medicare Part B Enrollment. Comments on the CMS/HHS Proposed Notice of Benefit and Payment Parameters for 2018. Medicare Supplemental Insurance. H.R. 6265, the Medigap Consumer Protection Act of 2016: proposal to improve access to and improve beneficiary information about Medigap for seniors and disabled individuals in the traditional Medicare program. Medicare Affordability. S. 3371, H.R. 6109, Medicare Affordability and Enrollment Act of 2016: proposals to improve Medicare for beneficiaries by capping out-of-pocket costs in traditional Medicare; increasing financial assistance for low-income beneficiaries; aligning the Medicare Savings Programs and Low-Income Subsidy; eliminating the 24- month waiting period for Medicare coverage for people receiving Social Security Disability Insurance benefits; making changes in the enrollment period for Medicare; eliminating gaps between enrollment and when actual coverage begins; limiting the Part B late enrollment penalty; and providing permanent funding for the State Health Insurance Assistance Programs (SHIPs), Area Agencies on Aging (AAAs), Aging and Disability Resource Centers ADRCs) and the National Center for Benefits Outreach and Enrollment. Medicare Part B Enrollment. S. 3236, H.R. 5772, the Beneficiary Enrollment Notification and Eligibility Simplification (BENES) Act: legislation to modernize and simplify Part B enrollment. Medicare Hearing Coverage. H.R. 1653, the Medicare Hearing Aid Coverage Act of 2015: proposal to provide Medicare coverage for the cost of hearing aids and examinations. Medicare Dental Coverage. S. 570, H.R. 1055, the Comprehensive Dental Reform Act of 2015: proposal to expand Medicare coverage to include dental care. Medicare Dental, Vision, and Hearing Coverage. H.R. 5396, H.R. 3308: Proposals to expand Medicare coverage to include comprehensive coverage of dental, vision, and hearing care. Home-based Primary Medical Care. S. 3130, Independence at Home Act of 2016: legislation to expand the Independence at Home Medicare demonstration project providing home-based primary medical care to elders with severe chronic illness and disability. Continuous Glucose Monitoring Devices. S. 804, Medicare CGM Access Act: legislation to provide Medicare coverage of continuous glucose monitoring (CGM) devices for beneficiaries with diabetes who meet specified medical criteria. Biologics Market Exclusivity Period. S. 3094, H.R. 5573, Price Relief, Innovation and Competition for Essential Drugs (PRICED) Act: legislation to reduce the market exclusivity period for biologics from its current 12 years to seven years. Drug Manufacture Transparency. S. 3335, H.R. 6043, Fair Accountability and Innovative Research Drug Pricing Act of 2016: proposal to require drug manufacturers to be more transparent about justification for increases in drug prices over ten percent, namely to report their spending on a drug's research and development as well as their profits on a drug each year since its approval. Drug Importation. H.R. 2623, the Personal Drug Importation Fairness Act: proposal to establish policies for the safe reimportation of pharmaceutical drugs by individuals for their personal use. Containment of Prescription Drug Costs. S. 2023, the Prescription Drug Affordability Act: proposals to require Medicare to negotiate drug prices under the Medicare Part D prescription drug program; allow for importation of prescription drugs from licensed Canadian pharmacies; require manufacturers to provide a rebate to the federal government for drugs covered under Medicare Part D for low-income Medicare beneficiaries; require generic drug manufacturers to pay an additional rebate to Medicaid if their drug prices rise faster than inflation; close the Medicare Part D donut hole for brand and generic drugs by 2017; and prohibit anti-competitive pay-for-delay arrangements between brand and generic drug makers. Medicare Prescription Drug Negotiation Authority. H.R. 4207, Medicare Fair Drug Pricing Act: proposal to allow the Secretary of Health and Human Services (HHS) to negotiate prices with pharmaceutical companies when drugs lack sufficient competition. Medicare Observation Status. S. 843, H.R. 1571, Improving Access to Medicare Coverage Act of 2015: proposal to count days in the hospital in observation status toward meeting the three-day prior hospitalization requirement for skilled nursing facility (SNF) care eligibility. Medicare Privatization. (No bill.) Proposals to transform traditional Medicare to a private insurance carrier program. Medicare Eligibility Age. (No bill.) Proposals to raise the eligibility age for Medicare from 65 to 67. Medicaid Restructuring. (No bill.) Proposals to change Medicaid from an entitlement program to block grants or per capita caps, forms of lump sum payments from the federal government. Affordable Care Act (ACA) repeal. (No bill.) Proposals to repeal the ACA affecting the closing of the Medicare Part D donut hole, Medicare coverage of ACA-mandated preventive services, and payment and delivery reforms that extend the life of the Medicare Part A Trust Fund. Childrens Health Insurance Program (CHIP) extension. (No bill.) Proposal to add an extension of the Medicare therapy cap exceptions process.

Client expense: $200,000 · Firm income: Not reported

Government targets: Administration on Aging, Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Economic Council (NEC), Office of Management & Budget (OMB), President of the U.S., SENATE, Social Security Administration (SSA), Treasury, Dept of, Vice President of the U.S.

A bill providing for comprehensive tax reform (Not introduced) H.R. 1741, Truth in Healthcare Marketing Act of 2015 H.R. 4565, Responsibility in Drug Advertising Act of 2016 S. 2623, Protecting Americans from Drug Marketing Act H.R. 6043/S. 3335, FAIR Drug Pricing Act FTC Reauthorization Act of 2016 (Not introduced)

Client expense: Not reported · Firm income: $170,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R.6 - Discussed the House Energy and Commerce Committee 21st Century Cures Initiative and Senate HELP Committee efforts focused on drug and medical device innovation issues. S. 31, H.R. 3061 - Discussed the importance of potential savings to both consumers and the federal government of granting Secretarial negotiating authority to the HHS Secretary under Medicare Part D. S. 2019 - Discussed legislation to address pay-for-delay agreements used by drug manufacturers to block lower cost drugs from entering the market. S. 3094, H.R. 5573 - Discussed legislation to reduce the market exclusivity period for biologic drugs. Discussed biologic drug issues including implementation of the new approval pathway for biosimilar drugs. S. 3335, H.R. 6043 - Discussed the need for price transparency on prescription drug prices and comparativeness effectiveness research. Discussed legislation to address the opioid abuse epidemic including fraud and abuse provisions. Discussed opioid issues generally. S. 3056 - Discussed legislation to address abuse of Risk-Evaluation and Mitigation Strategies (REMS) by brand name drug companies to block lower-cost generic drugs from entering the market. S. 3455 - Discussed legislation to allow temporary importation authority in cases of drug shortages and non-competitive markets. S. 2956, H.R. 5054, H.R. 5325, Agriculture Appropriations, FY2017 - Lobbied in support of FDA funding. H.R. 6043, FAIR Drug Pricing Act - Supported bill to require manufactures of certain drugs and biological products to report to HHS price increases that result in a 10% or more increase in the price of a drug over a 12 month period.

Client expense: $2,290,000 · 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), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Federal Transit Administration (FTA), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Pension Benefit Guaranty Corporation (PBGC), SENATE, Securities & Exchange Commission (SEC), Social Security Administration (SSA), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA), White House Office

S. 709, H.R. 1270, Restoring Access to Medication Act - Supported bill. H.R. 3590, Halt Tax Increases on the Middle Class and Seniors Act - Meetings, calls and emails urging support. Discussed the Fair Medical Billing Act. Discussed Medicare Advantage, Medicare Supplemental and employer health insurance. Discussed Affordable Care Act Medicaid expansion issues, including AARP comments on state 1115 waiver proposals to expand Medicaid. Discussed Medicare-Medicaid integration efforts and financial alignment demonstrations, other CMS demonstration initiatives. Discussed Older Americans Act home and community-based services program funding for FY2017. S. 2956, H.R. 5054 - Discussed nutrition programs including the Supplemental Nutrition Assistance Program (SNAP)and related changes under the 2014 farm bill. S. 3040, H.R. 5926, H.R. 5325, Labor, Health and Human Services Appropriations, FY2017 - Lobbied for funding support for various health and health care related programs serving seniors. S.3111, Seniors Tax Hike Prevention Act - Discussed medical expense deduction for the 65 plus population. Advocated on the issue of limited age rating for private health insurance. S. 3335, H.R. 6043, FAIR Drug Pricing Act - Supported bill.

Client expense: $2,290,000 · 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), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Federal Transit Administration (FTA), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Pension Benefit Guaranty Corporation (PBGC), SENATE, Securities & Exchange Commission (SEC), Social Security Administration (SSA), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA), 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.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.

H.R. 6, 21st Century Cures Act; S. 2700, FDA and NIH Workforce Authorities Modernization Act; Discussions to clarify or reform the 340B program; Biologics Price Competition and Innovation Act; H.R. 1101 & S. 1287, Viral Hepatitis Testing Act; Public Law 111-148, The Patient Protection and Affordable Care Act; H.R. 2228 & S.122, Safe and Affordable Drugs from Canada Act of 2015; Proposals to address prescription drug abuse; Implementation/Reauthorization of The Prescription Drug User Fee Act (PDUFA); Implementation/Reauthorization of The Biosimilars User Fee Act (BsUFA); H.R. 639 & S. 481, Improving Regulatory Transparency for New Medical Therapies; H.R. 2570 & S. 1396, Value-Based Insurance Design Seniors Copayment Reduction Act of 2015; H.R. 3677 Opioid Abuse Prevention and Treatment Act of 2015; S. 524, Comprehensive Addiction and Recovery Act of 2016; H.R. 3012 & S. 2912, Trickett Wendler Right to Try Act of 2016; H.R. 6043 & S. 3335, Fair Accountability and Innovative Research Drug Pricing Act of 2016; H.R. 6174, Closing Loopholes for Orphan Drugs Act; S.3239, RACE for Children Act; Expanded Access (legislation not introduced); H.R. 4207, Medicare Fair Drug Pricing Act of 2015; Clinton's 1993 Health Security Act;

Client expense: $1,920,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Medicare Payment Advisory Commission (MedPAC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

H.R. 9, Innovation Act (Goodlatte) - changes to inter partes review process H.R. 1600, Patients' Access to Treatments Act (McKinley-Capps) - specialty drug tiers H.R. 4599, Reducing Unused Medications Act (Clark) - partial fillings of prescriptions H.R. 4784, Lower Drug Costs Through Competition Act (Schrader-Bilirakis) - prescription drug issues H.R. 5122, Medicare Part B Prescription Drug Demonstration (Bucshon) H.R. 5951, Improving Transparency and Accuracy in Medicare Part D Spending Act (Griffith) - Medicare Part D pharmacy payments H.R. 6043, Fair Accountability and Innovative Research Drug Pricing Act (Schakowsky) - reporting requirements for prescription drug price increases S. 1137, PATENT Act (Grassley) - changes to inter partes review process S. 2019, Preserve Access to Affordable Generics Act (Klobuchar-Grassley) - pay-for-delay settlements S. 2023, Prescription Drug Affordability Act (Sanders) - pharmaceutical issues S. 2578, Reducing Unused Medications Act (Warren) - partial fillings of prescriptions S. 2615, Increasing Competition in Pharmaceuticals Act (Collins-McCaskill) - prescription drug issues S. 2689, REGROW Act (Kirk) - stem cell /regenerative medicines S. 3056, CREATES Act (Leahy) - challenging anti-competitive practices of brand name drug manufacturers S. 3308, Improving Transparency and Accuracy in Medicare Part D Spending Act (Capito) - Medicare Part D pharmacy payments S. 3335, Fair Accountability and Innovative Research Drug Pricing Act (Baldwin) - reporting requirements for prescription drug price increases Regulatory Issues: Issues relating to long term safety and effectiveness of medical devices and drugs, including registries; issues relating to post-market surveillance of drugs and medical devices; issues relating to price of drugs and biologics; issues relating to access for investigational drugs; 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

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)

Labor, Health and Human Services, Education, and Related Agencies Appropriations Bill, regarding all biopharmaceutical related provisions. Agriculture Appropriations, regarding all biopharmaceutical related provisions. H.R. 1078, FDA Safety Over Sequestration Act, regarding all biopharmaceutical related provisions. No bill, raised awareness about atrial fibrillation and stroke prevention. H/R. 1101, Viral Hepatitis Testing Act, regarding all biopharmaceutical related provisions. H.R.6, 21st Century Cures Initiative and Senate Innovation for a Healthier America proposal, regarding all biopharmaceutical related provisions. No Bill, lobbied Congress on biosimilar issues including naming, labeling and interchangeability. No Bill, lobbied Congress on importation of prescription drugs. S. 2912, Trickett Wendler Right to Try Act of 2016, S. 2912, regarding all biopharmaceutical related provisions. S. 3056, Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2016, regarding all biopharmaceutical related provisions. No Bill, Prescription Drug User Fee Act, regarding all biopharmaceutical related provisions. No Bill, Biosimilar User Fee Act, regarding all biopharmaceutical related provisions. S. 3335/H.R. 6043 the Fair Accountability and Innovative Research Drug Pricing Act, regarding all biopharmaceutical related provisions.

Client expense: $810,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Trade Representative (USTR)

S.524: Comprehensive Addiction and Recovery Act, focused on Prescription Drug Management Plans (PDMPs), Medicare lock-ins, partial fills and co-prescribing. S.480/H.R.1725: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015, educating on the importance of PDMPs and the need for federal funding. HR.4981: The Opioid Use Disorder Treatment Expansion and Modernization Act. H.R.4599/S.2578: Reducing Unused Medications Act of 2016. H.R.3680: Co-Prescribing to Reduce Overdoses Act of 2016. S.2256: Co-Prescribing Saves Lives Act of 2016. S.1945: Senate HELP mental health reform package, Mental Health Reform Act of 2016, mental health parity treatment of step therapy and prior-authorization. S.2615: Increasing Competition in Pharmaceuticals Act, support increasing generic availability. H.R.6: The 21st Century Cures Act and Senate companions, ensuring no new barriers to generic and biosimilar market entry. Generic Drug User Fee Act Reauthorization, support increasing generic availability. H.R.1600: The Patients' Access to Treatment Act, educating on the importance of step therapy to ensuring optimal therapy access and cost control. H.R.2841: the FAST Generics Act. S.3056: the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act. S.2700: Workforce Authorities Modernization Act, Section 11, Biological Product Innovation - treatment of USP compendia in approving biologics and biosimilars. Role of PBMs in Mylan pricing before Congressional hearings/investigation of Mylan. Drug pricing in general. H.R.6043 and S.3335, "Fair Accountability and Innovative Research Drug Pricing Act of 2016".

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 6 ,21st Century Cares H.R. 592/S. 314, Pharmacy and Medically Underserved Areas Enhancement Act H.R. 1190/S. 141, The Protecting Seniors Access to Medicare Act of 2015 H.R. 1192, National Diabetes 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. 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. 2646, Helping Families in Mental Crisis Act H.R. 3081/S. 1778, Telemedicine for Medicare Act H.R. 3660/S. 3126,Preventive Health Savings Act 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. 5395, Expanding Capacity for Health Outcomes 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. 6043/S. 3335, The Fair Accountability and Innovative Research Drug Pricing Act of 2016 S. 524, Comprehensive Addiction and Recovery Act S. 754, Cybersecurity Information Sharing Act (CISA) 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

Client expense: $140,000 · 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

Medicare Part B Premium. (No bill.) Proposals to mitigate the expected increase in the 2017 Part B premium for beneficiaries not protected by the hold harmless provision. Medigap. H.R. 6265, the Medigap Consumer Protection Act of 2016: proposal to improve access to and improve beneficiary information about Medigap for seniors and disabled individuals in the traditional Medicare program. Medicare Affordability. S. 3371, H.R. 6109, Medicare Affordability and Enrollment Act of 2016: proposals to improve Medicare for beneficiaries by capping out-of-pocket costs in traditional Medicare; increasing financial assistance for low-income beneficiaries; aligning the Medicare Savings Programs and Low-Income Subsidy; eliminating the 24-month waiting period for Medicare coverage for people receiving Social Security Disability Insurance benefits; making commonsense changes in the enrollment period for Medicare; eliminating gaps between enrollment and when actual coverage begins; limiting the Part B late enrollment penalty; and providing permanent funding for the State Health Insurance Assistance Programs (SHIPs), Area Agencies on Aging (AAAs), Aging and Disability Resource Centers (ADRCs) and the National Center for Benefits Outreach and Enrollment. Medicare Part B Enrollment. S. 3236, H.R. 5772, the Beneficiary Enrollment Notification and Eligibility Simplification (BENES) Act: legislation to modernize and simplify Part B enrollment. Medicare Observation Status. Public Law 114-42, Notice of Observation Treatment and Implication for Care Eligibility Act (NOTICE Act): comments on the CMS/HHS proposed rule to strengthen protections for Medicare beneficiaries who are hospitalized in observation status. Medicare Hearing Coverage. H.R. 1653, the Medicare Hearing Aid Coverage Act of 2015: proposal to provide Medicare coverage for the cost of hearing aids and examinations. Expanding Drug Monopolies. H.R. 6, 21st Century Cures Act. Proposal to extend orphan drug market exclusivity for existing drugs to new indications. Medicare Part B Drug Payments. H.R. 5122: legislation to prohibit the Department of Health and Human Services from taking any further action on a proposed rule to change how Medicare pays for certain drugs that are typically not self-administered (such as some intravenous medications and chemotherapy drugs). Drug Manufacture Transparency. S. 3335, H.R. 6043, Fair Accountability and Innovative Research Drug Pricing Act of 2016: proposal to require drug manufacturers to be more transparent about justification for increases in drug prices over ten percent, namely to report their spending on a drugs research and development as well as their profits on a drug each year since its approval. Biologics Market Exclusivity Period. S. 3094, H.R. 5573, Price Relief, Innovation and Competition for Essential Drugs (PRICED) Act: legislation to reduce the market exclusivity period for biologics from its current 12 years to seven years. Continuous Glucose Monitoring Devices. S. 804, Medicare CGM Access Act: legislation to provide Medicare coverage of continuous glucose monitoring (CGM) devices for beneficiaries with diabetes who meet specified medical criteria. Home-based Primary Medical Care. S. 3130, Independence at Home Act of 2016: legislation to expand the Independence at Home Medicare demonstration project providing home-based primary medical care to elders with severe chronic illness and disability. Alzheimers Beneficiary and Caregiver Assistance. S. 3137, H.R. 5681, Alzheimers Beneficiary and Caregiver Support Act: proposals to improve the quality of life for people living with Alzheimers disease and other forms of dementia, support family care partners, and reduce costs to federal and state health programs. Alzheimers Caregiver Support. S. 3113, H.R. 3039, Alzheimers Caregiver Support Act: legislation to provide vital support and training to people living with Alzheimers disease and other forms of dementia and to their caregivers. Medicare Payment Policy. Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2017 (CMS-16545-P): comments to CMS/HHS pertaining to the proposed rule for Sec. II. E. 5, Assessment and Care Planning for Patients with Cognitive Impairment, which recognizes the value of assessment and care planning services for patients with cognitive impairment, including people living with Alzheimers disease and other forms of dementia. Medicare End-Stage Renal Disease Prospective Payment System. End-Stage Renal Disease Prospective Payment System, Coverage and Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, Durable Medical Equipment, Prosthetics, Orthotics and Supplies Competitive Bidding Program Bid Surety Bonds, State Licensure and Appeals Process for Breach of Contract Actions, Durable Medical Equipment, Prosthetics, Orthotics and Supplies Competitive Bidding Program and Fee Schedule Adjustments, Access to Care Issues for Durable Medical Equipment; and the Comprehensive End-Stage Renal Disease Care Model (CMS-1651-P): comments to CMS/HHS regarding obstacles in many states to obtaining DME among people with Medicaid and Medicare benefits (dual eligibles).

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

Government targets: Administration on Aging, Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Economic Council (NEC), Office of Management & Budget (OMB), President of the U.S., SENATE, Social Security Administration (SSA), Treasury, Dept of, Vice President of the U.S.