DISARM Act of 2014

340B (no specific bill), National Diabetes Clinical Care Commission Act (H.R. 1074, S.539), Eliminating Disparities in Diabetes Prevention Act (H.R. 3322), Oncology education (no specific bill), adult vaccine policies (no specific bill), medication adherence, DISARM (H.R. 4187), ACA Implementation (no specific bill), Hepatitis C education (no specific bill), HIV education (no specific bill), MODDERN Cures Act of 2013 (H.R. 3116), biosimilars (no specific bill), Alzheimer's education (no specific bill)21st Century Cures (no specific bill), general pharmaceutical industry issues and education

Client expense: $490,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Budget and appropriations for disease and injury prevention, including obesity and related diseases; pandemic influenza and emerging infectious diseases; physical activity; public health bioterrorism preparedness; food safety, environmental health; paid sick days; womens and childrens health; community-based public health interventions and prescription drug abuse. 1.Implementation of the Patient Protection and Affordable Care Act (Public Law 111-148) 2.Implementation of the FDA Food Safety Modernization Act (Public Law 111-353) 3.Implementation of Pandemic and All-Hazards Preparedness Reauthorization Act (Public Law 113-5) 4.Implementation of Healthy, Hunger-Free Kids Act of 2010 (Public Law 111-296) 5.Implementation of the Budget Control Act of 2011 (Public Law 112-25) 6.Delivering Antimicrobial Transparency in Animals Act of 2013 (H.R. 820) 7.Animal Drug and Animal Generic Drug User Fee Act (Public Law 113-14) 8.Healthier Lifestyles and Prevention America Act (S. 39) 9.Promoting Health as Youth Skills in Classrooms and Life Act (S. 392/H.R. 2160) 10.Medicare Diabetes Prevention Act (S. 452/H.R. 962) 11.Personal Health Investment Today Act (H.R. 956) 12.A bill to provide for a sequester replacement (S. 16/S. 799) 13.American Family Economic Protection Act of 2013 (S. 388) 14.Consolidated and Further Continuing Appropriations Act, 2013 (H.R. 933/Public Law 113-6) 15.Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (Public Law 113-5) 16.National Diabetes Clinical Care Commission Act (H.R. 1074/S. 539) 17.Physical Activity Guidelines for Americans Act (S. 531/H.R. 2179) 18.Firearm Safety and Public Health Research Act (H.R. 321) 19.Energy Consumers Relief Act (S. 1363/H.R. 1582) 20.Common Sense Nutrition Disclosure Act (H.R. 1249/S. 1756) 21.Improve Nutrition Program Integrity and Deficit Reduction Act (S. 458/H.R. 1510) 22.A bill to amend the Food and Nutrition Act of 2008 to improve the supplemental nutrition assistance program (S. 762/H.R. 1657) 23.Agriculture Reform, Food, and Jobs Act (S. 954/H.R. 2498) 24.Federal Agriculture Reform and Risk Management Act (H.R. 1947) 25.FIT Kids Act (S. 1033/H.R. 2178) 26.Strengthening Americas Schools Act (S. 1094) 27.Access to Quality Diabetes Education Act (S. 945/H.R. 1274) 28.Fit to Serve Act (S. 976) 29.Climate Change Health Protection and Promotion Act (H.R. 2023/S. 2864) 30.Treat and Reduce Obesity Act (S. 1184 / H.R. 2415) 31.Student Success Act (H.R. 5) 32.To repeal the Patient Protection and Affordable Care Act and health care-related provisions in the Health Care and Education Reconciliation Act (H.R. 45) 33.Medicare Better Health Rewards Program Act (S. 1228/H.R. 2524) 34.Senate FY14 Labor, Health and Human Services, and Education Bill (S. 1284) 35.House of Representatives FY14 Labor, Health and Human Services, and Education Bill 36.Pharmacy Compounding Quality and Accountability Act (S. 959) 37.Safeguarding Americas Pharmaceuticals Act (H.R. 1919) 38.Implementation of Drug Supply Chain Security Act (P.L. 113-54) 39.Preservation of Antibiotics for Medical Treatment Act (H.R. 1150)/Preventing Antibiotic Resistance Act of 2013 (S. 1256) 40.Healthy Families Act (H.R. 1286/S. 631) 41.FY2014 Continuing Resolution (H.J. Res. 59) 42.Pharmaceutical Quality, Security and Accountability Act (S. 959) 43.Energy Consumers Relief Act (S. 1363/H.R. 1582) 44.Increasing the Safety of Prescription Drug Use Act (S. 1657) 45.National Energy Tax Repeal Act (S. 1324) 46.Saving Coal Jobs Act of 2013 (S. 1514/H.R. 5077) 47.Community Parks Revitalization Act (H.R. 2424) 48.A bill to amend the Congressional Budget Act of 1974 respecting the scoring of preventive health savings (S. 1422/H.R. 2663) 49.School-based Health Centers Program Reauthorization Act of 2013 (H.R. 2632) 50.Nutrition Reform and Work Opportunity Act (H.R. 3102) 51.Health Equity and Accountability Act (H.R. 5294) 52.Secure America for Education (SAFE) in Our Schools Act of 2013 (H.R. 3158) 53.Continuing Appropriations Resolution, 2014 (H.J. Res 59) 54.Continuing Resolution FY 2014 (HR 2775, PL 113-46) 55.A bill to amend title 23, United States Code, with respect to the establishment of performance measures for the highway safety improvement program, and for other purposes. (H.R. 3493/S. 1708) 56.The Farm Bill (S. (S. 954/H.R. 2498; H.R. 1947, and H.R. 3102, Public Law 113-79) 57.Better Care, Lower Cost Act (S. 1932/H.R. 3890) 58.Antibiotic Development to Advance Patient Treatment Act of 2013 (ADAPT Act) (H.R. 3742) 59.The Consolidated Appropriations Act of 2014 (H.R. 3547/Public Law 113-76 60.Strategies to Address Antimicrobial Resistance (STAAR) Act (S. 2236/H.R. 2285) 61.New Opportunities for Bicycling and Pedestrian Infrastructure Financing Act of 2014 (H.R. 3978) 62.Eliminating Disparities in Diabetes Prevention, Access, and Care Act (H.R. 3322) 63.Electricity Security and Affordability Act (S. 1905/H.R. 3826) 64.Stop Overdose Stat Act (HR 4169) 65.Overdose Prevention Act (S 2755) 66.Opioid Overdose Reduction Act (S. 2092/H.R. 4288) 67.Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2014 (DISARM Act) (H.R. 4187) 68.Child Care and Development Block Grant Act of 2014 (S. 1086) 69.Departments of Labor, Health and Human Services and Education And Related Agencies Fiscal Year 2015 Appropriations Bill (including H.R. 5464) 70.Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2015 (S. 2389 / H.R. 4800) 71.Department of the Interior, Environment, and Related Agencies appropriations legislation, 2015 (including H.R. 5171) 72.MAP-21 Reauthorization Act (S. 2322) 73.Stop Subsidizing Childhood Obesity Act (S. 2342/H.R. 2831) 74.ENRICH Act (H.R. 4427) 75.Healthy Kids Outdoors Act of 2014 (S. 2367/H.R. 4706) 76.Summer Meals Act of 2014 (S. 2527/HR. 5012) 77.Long-Term SCORE Act (H.R. 4444) 78.American Cures Act (S. 2115/H.R. 4384) 79.A joint resolution to disapprove a rule of the Environmental Protection Agency relating to greenhouse gas emissions from electric utility generating units. (S.J. Res 30) 80.Fit for Life Act of 2014 (H.R.4765) 81.School Food Modernization Act (S. 2210/H.R. 1783) 82.Protecting Children from Electronic Cigarette Advertising Act of 2014 (S. 2014/H.R. 4325) 83.Pedestrian Safety Act of 2014 (S. 2284) 84.Safe Streets Act of 2014 (S. 2004/H.R. 2468) 85.Time for Recovery Enhancement for Addiction Treatment Act (S. 2645) 86.FY 2015 Financial Services and General Government Appropriations bill, in support of an appropriation for the National Alliance for Model State Drug Laws (including H.R. 5016) 87.Vector-Borne Disease Research Accountability and Transparency Act (H.R. 4701) 88.Highway and Transportation Funding Act of 2014 (H.R. 5021/Public Law 113-159) 89.Full-Service Community Schools Act of 2014 (H.R. 5168) 90.PREPARE Act of 2014 (H.R. 5314) 91.Waters of the United States Regulatory Overreach Protection Act of 2014 (S. 2496/H.R. 5078) 92.American Energy Solutions for Lower Costs and More American Jobs Act (H.R. 2) 93.FY2015 Omnibus; Consolidated and Further Continuing Appropriations Act (H.R. 83/Public Law 113-234) 94.Promise for Antibiotics and Therapeutics for Health Act (PATH Act, S. 2996) 95.Infectious Disease Hospital Hubs Act (S. 2942)

Client expense: $39,000 · Firm income: Not reported

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

340B (no specific bill), National Diabetes Clinical Care Commission Act (H.R. 1074, S.539), Eliminating Disparities in Diabetes Prevention Act (H.R. 3322), Oncology education (no specific bill), adult vaccine policies (no specific bill), medication adherence, DISARM (H.R. 4187), ACA Implementation (no specific bill), Hepatitis C education (no specific bill), HIV education (no specific bill), MODDERN Cures Act of 2013 (H.R. 3116), Prescription Drug User Fee Act (general planning), 21st Century Cures (no specific bill), Strengthening Medicare Anti-Fraud Measures Act of 2013 (H.R. 2925), Big data (general education), Alzheimer's education (no specific bill), biosimilars (general education, no specific bill), general pharmaceutical industry issues and education.

Client expense: $1,160,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Implementation of the Affordable Care Act of 2010 (Pub. L. 111-148) Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152) Implementation of the Food and Drug Administration Safety and Innovation Act(FDASIA) Pub.L. 112-144) H.R. 1919 the Safeguarding America's Pharmaceuticals Act of 2013 H.R. 3742, Antibiotic Development to Advance Patient Treatment (ADAPT) Act H.R. 4187, Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act House Committee on Energy & Commerce 21st Century Cures initiative.

Client expense: Not reported · Firm income: $54,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Ongoing discussions surrounding next steps for protecting and promoting incentives for the development of resistant pathogens including breakpoints Antibiotic resistance Reimbursement issues for antibiotics H.R. 4187, DISARM - Developing An Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2014 Presidents Council of Advisors on Science and Technology (PCAST) and their recent report on antibiotic resistance LPAD (Limited Population Antibacterial Drug) proposal

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

Government targets: Health & Human Services, Dept of (HHS), SENATE

Issues related to the implementation of health care reform (P.L. 111-148, P.L. 111-152); Issues related to the Medicare hospital outpatient issues (H.R. 4857, S. 2980); Developing an Innovative Strategy for Antimicrobial Resistance Microorganisms Act of 2014 (DISARM) (H.R. 4187)

Client expense: $440,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Development of policies to advance the antimicrobial research and development environment. Support of H.R.4187 - "DISARM Act of 2014."

Client expense: Not reported · Firm income: $7,500

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Implementation of the Affordable Care Act of 2010 (Pub. L. 111-148), Health Care and Education Reconciliation Act of 2010 (Pub.L. 111-152), Implementation of the Food and Drug Administration Safety and Innovation Act (FDASIA) Pub.L. 112-144), H.R. 919 the Safeguarding America's Pharmaceuticals Act of 2013, H.R. 3742, Antibiotic Development to Advance Patient Treatment (ADAPT) Act, H.R. 4187, Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act, House Committee on Energy & Commerce 21st Century Cures initiative. Ongoing discussions surrounding next steps for protecting and promoting incentives for the development of resistant pathogens including breakpoints, antibiotic resistance, reimbursement issues for antibiotics, President's Council of Advisors on Science and Technology (PCAST) and their recent report on antibiotic resistance, LPAD (Limited Population Antibacterial Drug) proposal

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Development of policies to advance the antimicrobial research and development environment. Support of H.R.4187 - "DISARM Act of 2014."

Client expense: Not reported · Firm income: $7,500

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Development of policies to advance the antimicrobial research and development environment. Support of H.R.4187 - "DISARM Act of 2014."

Client expense: Not reported · Firm income: $7,500

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Development of policies to advance the antimicrobial research and development environment. Support of H.R.4187 - "DISARM Act of 2014."

Client expense: Not reported · Firm income: $7,500

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Development of policies to advance the antimicrobial research and development environment. Support of H.R.4187 - "DISARM Act of 2014."

Client expense: Not reported · Firm income: $7,500

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Development of policies to advance the antimicrobial research and development environment. Support of H.R.4187 - "DISARM Act of 2014."

Client expense: Not reported · Firm income: $7,500

Government targets: HOUSE OF REPRESENTATIVES, SENATE

General health care coverage and reimbursement; issues related to infectious disease drug development and procurement; legislative and regulatory issues related to biodefense countermeasure development and procurement, H.R.4187 - "DISARM Act of 2014"; Food and Drug Administration legislative and regulatory issues.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

340B (no specific bill), National Diabetes Clinical Care Commission Act (H.R. 1074, S.539), Eliminating Disparities in Diabetes Prevention Act (H.R. 3322), Oncology education (no specific bill), adult vaccine policies (no specific bill), medication adherence, DISARM (H.R. 4187), ACA Implementation (no specific bill), Hepatitis C education (no specific bill), HIV education (no specific bill), MODDERN Cures Act of 2013 (H.R. 3116), biosimilars (no specific bill), Alzheimer's education (no specific bill)21st Century Cures (no specific bill), general pharmaceutical industry issues and education

Client expense: $460,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 4187, the "Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act." Public Law No. 112-144, the "Food and Drug Administration Safety and Innovation Act," specifically those sections relating to implementation of the Prescription Drug User Fee program. Policy and implementation issues relating to Public Law No. 111-148, the "Patient Protection and Affordable Care Act."

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H. Con. Res. 96, Establishing the budget for the United States Government for fiscal year 2015 and setting forth appropriate budgetary levels for fiscal years 2016 through 2024, (potential provisions relating to Medicare Part D and the establishment of a Medicaid style "rebate"). S. 2110, Medicare SGR Repeal and Beneficiary Access Improvement Act (potential programmatic offsets).Potential deficit reduction legislation that might include provisions to reduce Medicare Part B reimbursements for drugs and biologics. H.R.1588, Medicare Drug Savings Act of 2013 (provisions relating to Medicare Part D and the establishment of a Medicaid style mandatory rebate on prescription drugs). H.R. 4302, Protecting Access to Medicare Act of 2014, (potential programmatic offsets). H.R. 4187, Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2014 H.R. 83, Consolidated and Further Continuing Appropriations Act, 2015 (potential programmatic offsets).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to Medicare reimbursement of antibiotics; H.R. 4187, Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms.

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

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

Medicare Physician Payment Reform; in general. H.R. 4015/S. 2000, the SGR Repeal and Medicare Provider Payment Modernization Act of 2014; all provisions. S. 2110, the Medicare SGR Repeal and Beneficiary Access Improvement Act of 2014; all provisions. S. 2122, the Responsible Medicare SGR Repeal and Beneficiary Access Improvement Act of 2014; all provisions. S. 2157, the Commonsense Medicare SGR Repeal and Beneficiary Access Improvement Act of 2014; all provisions. H.R. 4302, the Protecting Access to Medicare Act of 2014; all provisions. Audiology-related legislation, in general. H.R. 2330, the Medicare Audiology Services Enhancement Act of 2013; all provisions. H.R. 4035/S. 2046, the Access to Hearing Healthcare Act of 2014; all provisions. Repeal of the Independent Payment Advisory Board (IPAB); in general. Issue regarding Medicare appeals backlog; in general. Compliance with the Medicare and Medicaid Electronic Health Record (EHR) Incentive Program; in general. Standards for electronic health records (EHR) Meaningful Use; in general. Comments on final 2014 Medicare Physician Fee Schedule rule; in general. Support for increased transparency at CMS to ensure that the rulemaking process for changes to the Medicare physician fee schedule under the misvalued codes initiative is transparent and allows for sufficient input by stakeholders well before the new values are implemented. H.R. 4695, a bill to amend title XVIII of the Social Security Act to add sleep apnea screening to the initial preventive physical examination under the Medicare program; all provisions. Comments re: CMS' final rule entitled Medicare and Medicaid Programs; Regulatory Provisions To Promote Program Efficiency, Transparency, and Burden Reduction; Part II [CMS-3267-F] relating to changes to the Medicare hospital Conditions of Participation (CoPs). H.R. 4187, legislation to modify the current Medicare New Technology Add-on Payment (NTAP) Program to provide a new supplemental payment for certain antimicrobial drugs used in the hospital setting. H.R. 5304, the Audiology Patient Choice Act of 2014; all provisions. Concerns pertaining to implementation of the Physician Payments Sunshine Act (Sunshine Act) and subsequent requests for an expanded timeframe to allow recipients to register, review, and dispute their data in the Open Payments System before publication. Support for additional transparency and comment opportunity in the valuation of physician and other healthcare professional services re: Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule, Clinical Laboratory Fee Schedule, Access to Identifiable Data for the Centers for Medicare and Medicaid Innovation Models & Other Revisions to Part B for CY 2015 - Proposal to Modify the Process for Establishing Values for New, Revised and Potentially Misvalued Codes. Comments re: the "Medicare Program; End-Stage Renal Disease Prospective Payment System, Quality Incentive Program, and Durable Medical Equipment, Prosthetics, Orthotics, and Supplies" published in the Federal Register as a proposed notice on July 11, 2014; provisions relating to the revision of the hearing aid exclusion to encompass osseointegrated implants and all other bone conducting prosthetics. Comments on the "Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule, Clinical Laboratory Schedule & Other Revisions to Part B for CY 2015" published under the Federal Register as a proposed notice on July 11, 2014. Provisions relating to: (1) Sustainable Growth Rate (SGR); (2) Resource Based Practice Expense (PE) Relative Value Units (RVUs); (3) Potentially Misvalued Services Under the Fee Schedule; (4) Validating RVUs of Services; (5) Payment for Secondary Interpretation of Images; (6) Physician Compare Website; (7) Electronic Health Records (EHR) Meaningful Use (MU) Incentive Program; (8) Physician Quality Reporting System; and (9) Value Based Payment Modifier and Physician Feedback Program. Support for H.R. 5539, which would clarify that certain applicable manufacturer transfers of value to support independent medical educational programs and materials are exempt from reporting under the Physician Payments Sunshine Act (Sunshine Act). Comments regarding recent improvements and changes to the National Quality Forum (NQF) measure endorsement process; in general. Opposition to proposed policy in the 2015 Final Medicare Physician Fee Schedule Rule to transition 10- and 90-day global payment period codes to 0-day global period codes in 2017, and 2018, respectively. Comments re: the Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule, Clinical Laboratory Schedule & Other Revisions to Part B for CY 2015 published in the Federal Register as a proposed notice on October 31, 2014. Our comments addressed the following issues, in the order in which they appear in the proposed rule: (1) Sustainable Growth Rate (SGR); (2) Resource Based Practice Expense (PE) Relative Value Units (RVUs); (3) Potentially Misvalued Services Under the Fee Schedule; (4) Validating RVUs of Services; (5) Payment for Secondary Interpretation of Images; (6) Physician Compare Website; (7) Electronic Health Records (EHR) Meaningful Use (MU) Incentive Program; (8) Physician Quality Reporting System; and (9) Value Based Payment Modifier and Physician Feedback Program.

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), General Services Administration (GSA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA)

Medicare Coverage and Reimbursement issues; Medicare access to DXA services; Medicare reimbursement for antimicrobial drugs, including related provisions in HR 4187, The Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2014.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 351 - Protecting Seniors' Access to Medicare Act of 2013; provisions related to the Independent Payment Advisory Board H.R. 928 - Medicare Prescription Drug Savings and Choice Act of 2013; provisions related to Medicare Part D H.R. 1024 - Medication Therapy Empowerment Act of 2013; provisions related to Part D issues H.R. 1102 - Medicare Prescription Drug Price Negotiation Act of 2013; Provisions related to Part D issues and non-interference H.R. 1588 - Medicare Drug Savings Act of 2013; provisions related to Part D issues H.R. 2810 - Medicare Patient Access and Quality Improvement Act of 2013; Provisions related to SGR reform H.R. 2827 - To amend title XVIII of the Social Security Act to allow for fair application of the exceptions process for drugs in tiers in formularies in prescription drug plans under Medicare part D; provisions related to Medicare Part D Drug Tier Formularies H.R. 3890 - Better Care, Lower Cost Act; Provisions related to Part D, value-based insurance design, and chronic disease H.R 4160 - Keep the Promise to Seniors Act of 2014; provisions related to Part D H.R. 4187 - Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act H.R. 4302 - Protecting Access to Medicare Act of 2014; provisions related to the biopharmaceutical industry S. 117 - Medicare Prescription Drug Price Negotiation Act of 2013; provisions related to Part D issues S. 351 - Protecting Seniors' Access to Medicare Act of 2013; provisions related to the Independent Payment Advisory Board S. 408 - Medicare Prescription Drug Savings and Choice Act of 2013; provisions related to Medicare Part D S. 557 - Medication Therapy Empowerment Act of 2013; provisions related to Part D issues S. 740 - Medicare Drug Savings Act of 2013; provisions related to Part D issues S. 1871 - SGR Repeal and Medicare Beneficiary Access Act of 2013; Provisions related to reforming Medicare physician payments S. 1932 - Better Care, Lower Cost Act; Provisions related to Part D, value-based insurance design, and chronic disease S. 2000 - SGR Repeal and Medicare Provider Payment Modernization Act of 2014; Provisions related to SGR reform S. 2110 - Medicare SGR Repeal and Beneficiary Access Improvement Act of 2014; Provisions related to SGR reform No bill # assigned - Contract Year 2015 Policy and Technical Cganges to the Medicare Advantage and the Medicare Prescription Drug Benefits Programs; Provisions related to Part D No bill # assigned - Proposals to increase co-payments for Part D beneficiaries receiving the low-income subsidy No bill # assigned - Issues related to better use of medicines and comprehensive medication management No bill # assigned - Medicaid Program, Covered Outpatient Drugs rulemaking No bill # assigned - Implementation Issues relating to the Physician Payment Sunshine ActNo bill # assigned - Vaccine access and coverage issues

Client expense: $580,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)

Implementation issues related to the Pharmaceutical Quality, Security, and Accountability Act (P.L. 113-54), the Patient Protection and Affordable Care Act (P.L. 111-148) and the Food and Drug Administration Safety and Innovation Act (P.L. 112-144). H.R.4187, DISARM Act of 2014. Issues related to health care and the Food and Drug Administration (FDA). Issues related to the 340B Program.

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

Government targets: Agriculture, Dept of (USDA), HOUSE OF REPRESENTATIVES, SENATE

Implementation of the "GAIN" provisions/Title VIII of the Food and Drug Administration Safety and Innovation Act (FDASIA) - PL 112-144; antibiotic product development incentive, limited population antibiotic product (LPAD) and breakpoint legislation HR 3742 -- the Antibiotic Development to Advance Patient Treatment Act of 2013 H.R.4187 -- Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2014 antibiotic product incentives for possible inclusion in the House "21st Century Cures" effort

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 4302 Protecting Access to Medicare Act of 2014 - Public Law No: 113-93 In the above the specific issues included potential Medicare offsets that might be applied to prescription drugs H.R.4187 -- Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2014

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicare medicaid legislationH.R. 351 - Protecting Seniors' Access to Medicare Act of 2013; provisions related to the Independent Payment Advisory Board H.R. 928 - Medicare Prescription Drug Savings and Choice Act of 2013; provisions related to Medicare Part D H.R. 1024 - Medication Therapy Empowerment Act of 2013; provisions related to Part D issues H.R. 1102 - Medicare Prescription Drug Price Negotiation Act of 2013; Provisions related to Part D issues and non-interference H.R. 1588 - Medicare Drug Savings Act of 2013; provisions related to Part D issues H.R. 2810 - Medicare Patient Access and Quality Improvement Act of 2013; Provisions related to SGR reform H.R. 2827 - To amend title XVIII of the Social Security Act to allow for fair application of the exceptions process for drugs in tiers in formularies in prescription drug plans under Medicare part D; provisions related to Medicare Part D Drug Tier Formularies H.R. 3890 - Better Care, Lower Cost Act; Provisions related to Part D, value-based insurance design, and chronic disease H.R 4160 - Keep the Promise to Seniors Act of 2014; provisions related to Part D H.R. 4187 - Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act H.R. 4302 - Protecting Access to Medicare Act of 2014 - provisions related to the biopharmaceutical industry S. 117 - Medicare Prescription Drug Price Negotiation Act of 2013; provisions related to Part D issues S. 351 - Protecting Seniors' Access to Medicare Act of 2013; provisions related to the Independent Payment Advisory Board S. 408 - Medicare Prescription Drug Savings and Choice Act of 2013; provisions related to Medicare Part D S. 557 - Medication Therapy Empowerment Act of 2013; provisions related to Part D issues S. 740 - Medicare Drug Savings Act of 2013; provisions related to Part D issues S. 1871 - SGR Repeal and Medicare Beneficiary Access Act of 2013; Provisions related to reforming Medicare physician payments S. 1932 - Better Care, Lower Cost Act; Provisions related to Part D, value-based insurance design, and chronic disease S. 2000 - SGR Repeal and Medicare Provider Payment Modernization Act of 2014; Provisions related to SGR reform S. 2110 - Medicare SGR Repeal and Beneficiary Access Improvement Act of 2014; Provisions related to SGR reform

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Budget and appropriations for disease and injury prevention, including obesity and related diseases; pandemic influenza and emerging infectious diseases; physical activity; public health bioterrorism preparedness; food safety, environmental health; paid sick days; womens and childrens health; and community-based public health interventions and prescription drug abuse. 1. Implementation of the Patient Protection and Affordable Care Act (Public Law 111-148)2.Implementation of the FDA Food Safety Modernization Act (Public Law 111-353) 3.Implementation of Pandemic and All-Hazards Preparedness Reauthorization Act (Public Law 113-5) 4.Implementation of Healthy, Hunger-Free Kids Act of 2010 (Public Law 111-296) 5.Implementation of the Budget Control Act of 2011 (Public Law 112-25) 6.Delivering Antimicrobial Transparency in Animals Act of 2013 (H.R. 820) 7.Animal Drug and Animal Generic Drug User Fee Act (Public Law 113-14) 8.Healthier Lifestyles and Prevention America Act (S. 39) 9.Promoting Health as Youth Skills in Classrooms and Life Act (S. 392/H.R. 2160) 10.Medicare Diabetes Prevention Act (S. 452/H.R. 962) 11.Personal Health Investment Today Act (H.R. 956) 12.A bill to provide for a sequester replacement (S. 16/S. 799) 13.American Family Economic Protection Act of 2013 (S. 388) 14.Consolidated and Further Continuing Appropriations Act, 2013 (H.R. 933/Public Law 113-6) 15.Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (Public Law 113-5) 16.National Diabetes Clinical Care Commission Act (H.R. 1074/S. 539) 17.Physical Activity Guidelines for Americans Act (S. 531/H.R. 2179) 18.Firearm Safety and Public Health Research Act (H.R. 321) 19.Energy Consumers Relief Act (S. 1363/H.R. 1582) 20.Common Sense Nutrition Disclosure Act (H.R. 1249/S. 1756) 21.Improve Nutrition Program Integrity and Deficit Reduction Act (S. 458/H.R. 1510) 22.A bill to amend the Food and Nutrition Act of 2008 to improve the supplemental nutrition assistance program (S. 762/H.R. 1657) 23.Agriculture Reform, Food, and Jobs Act (S. 954/H.R. 2498) 24.Federal Agriculture Reform and Risk Management Act (H.R. 1947) 25.FIT Kids Act (S. 1033/H.R. 2178) 26.Strengthening Americas Schools Act (S. 1094) 27.Access to Quality Diabetes Education Act (S. 945/H.R. 1274) 28.Fit to Serve Act (S. 976) 29.Climate Change Health Protection and Promotion Act (H.R. 2023/S. 2864) 30.Treat and Reduce Obesity Act (S. 1184 / H.R. 2415) 31.Student Success Act (H.R. 5) 32.To repeal the Patient Protection and Affordable Care Act and health care-related provisions in the Health Care and Education Reconciliation Act (H.R. 45) 33.Medicare Better Health Rewards Program Act (S. 1228/H.R. 2524) 34.Senate FY14 Labor, Health and Human Services, and Education Bill (S. 1284) 35.House of Representatives FY14 Labor, Health and Human Services, and Education Bill 36.Pharmacy Compounding Quality and Accountability Act (S. 959) 37.Safeguarding Americas Pharmaceuticals Act (H.R. 1919) 38.Implementation of Drug Supply Chain Security Act (P.L. 113-54) 39.Preservation of Antibiotics for Medical Treatment Act (H.R. 1150)/Preventing Antibiotic Resistance Act of 2013 (S. 1256) 40.Healthy Families Act (H.R. 1286/S. 631) 41.FY2014 Continuing Resolution (H.J. Res. 59) 42.Pharmaceutical Quality, Security and Accountability Act (S. 959) 43.Energy Consumers Relief Act (S. 1363/H.R. 1582) 44.Increasing the Safety of Prescription Drug Use Act (S. 1657) 45.National Energy Tax Repeal Act (S. 1324) 46.Saving Coal Jobs Act of 2013 (S. 1514/H.R. 5077) 47.Community Parks Revitalization Act (H.R. 2424) 48.A bill to amend the Congressional Budget Act of 1974 respecting the scoring of preventive health savings (S. 1422/H.R. 2663) 49.School-based Health Centers Program Reauthorization Act of 2013 (H.R. 2632) 50.Nutrition Reform and Work Opportunity Act (H.R. 3102) 51.Health Equity and Accountability Act (H.R. 5294) 52.Secure America for Education (SAFE) in Our Schools Act of 2013 (H.R. 3158) 53.Continuing Appropriations Resolution, 2014 (H.J. Res 59) 54.Continuing Resolution FY 2014 (HR 2775, PL 113-46) 55.A bill to amend title 23, United States Code, with respect to the establishment of performance measures for the highway safety improvement program, and for other purposes. (H.R. 3493/S. 1708) 56.The Farm Bill (S. (S. 954/H.R. 2498; H.R. 1947, and H.R. 3102, Public Law 113-79) 57.Better Care, Lower Cost Act (S. 1932/H.R. 3890) 58.Antibiotic Development to Advance Patient Treatment Act of 2013 (ADAPT Act) (H.R. 3742) 59.The Consolidated Appropriations Act of 2014 (H.R. 3547/Public Law 113-76 60.Strategies to Address Antimicrobial Resistance (STAAR) Act (S. 2236/H.R. 2285) 61.New Opportunities for Bicycling and Pedestrian Infrastructure Financing Act of 2014 (H.R. 3978) 62.Eliminating Disparities in Diabetes Prevention, Access, and Care Act (H.R. 3322) 63.Electricity Security and Affordability Act (S. 1905/H.R. 3826) 64.Stop Overdose Stat Act (HR 4169) 65.Overdose Prevention Act (S 2755) 66.Opioid Overdose Reduction Act (S. 2092/H.R. 4288) 67.Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2014 (DISARM Act) (H.R. 4187) 68.Child Care and Development Block Grant Act of 2014 (S. 1086) 69.Departments of Labor, Health and Human Services and Education And Related Agencies Fiscal Year 2015 Appropriations Bill (including H.R. 5464) 70.Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2015 (S. 2389 / H.R. 4800) 71.Department of the Interior, Environment, and Related Agencies appropriations legislation, 2015 (including H.R. 5171) 72.MAP-21 Reauthorization Act (S. 2322) 73.Stop Subsidizing Childhood Obesity Act (S. 2342/H.R. 2831) 74.ENRICH Act (H.R. 4427) 75.Healthy Kids Outdoors Act of 2014 (S. 2367/H.R. 4706) 76.Summer Meals Act of 2014 (S. 2527/HR. 5012) 77.Long-Term SCORE Act (H.R. 4444) 78.American Cures Act (S. 2115/H.R. 4384) 79.A joint resolution to disapprove a rule of the Environmental Protection Agency relating to greenhouse gas emissions from electric utility generating units. (S.J. Res 30) 80.Fit for Life Act of 2014 (H.R.4765) 81.School Food Modernization Act (S. 2210/H.R. 1783) 82.Protecting Children from Electronic Cigarette Advertising Act of 2014 (S. 2014/H.R. 4325) 83.Pedestrian Safety Act of 2014 (S. 2284) 84.Safe Streets Act of 2014 (S. 2004/H.R. 2468) 85.The Recovery Enhancement for Addiction Treatment Act (S. 2645) 86.FY 2015 Financial Services and General Government Appropriations bill, in support of an appropriation for the National Alliance for Model State Drug Laws (including H.R. 5016) 87.Vector-Borne Disease Research Accountability and Transparency Act (H.R. 4701) 88.Highway and Transportation Funding Act of 2014 (H.R. 5021/Public Law 113-520) 89.Full-Service Community Schools Act of 2014 (H.R. 5168) 90.PREPARE Act of 2014 (H.R. 5314) 91.Waters of the United States Regulatory Overreach Protection Act of 2014 (S. 2496/H.R. 5078) 92.American Energy Solutions for Lower Costs and More American Jobs Act (H.R.

Client expense: $38,000 · Firm income: Not reported

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

Issues related to the implementation of health care reform (P.L. 111-148, P.L. 111-152). Issues related to the Medicare hospital outpatient issues (H.R.4857). Developing an Innovative Strategy for Antimicrobial Resistance Microorganisms Act of 2014 (DISARM) (H.R. 4187)

Client expense: $400,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Development of policies to advance the antimicrobial research and development environment. Support of H.R.4187 - "DISARM Act of 2014."

Client expense: Not reported · Firm income: $7,500

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Development of policies to advance the antimicrobial research and development environment. Support of H.R.4187 - "DISARM Act of 2014."

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Development of policies to advance the antimicrobial research and development environment. Support of H.R.4187 - "DISARM Act of 2014."

Client expense: Not reported · Firm income: $7,500

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Development of policies to advance the antimicrobial research and development environment. Support of H.R.4187 - "DISARM Act of 2014."

Client expense: Not reported · Firm income: $7,500

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Development of policies to advance the antimicrobial research and development environment. Support of H.R.4187 - "DISARM Act of 2014."

Client expense: Not reported · Firm income: $7,500

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Development of policies to advance the antimicrobial research and development environment. Support of H.R.4187 - "DISARM Act of 2014."

Client expense: Not reported · Firm income: $7,500

Government targets: HOUSE OF REPRESENTATIVES, SENATE

General health care coverage and reimbursement; issues related to infectious disease drug development and procurement; legislative and regulatory issues related to biodefense countermeasure development and procurement, H.R.4187 - "DISARM Act of 2014"; Food and Drug Administration legislative and regulatory issues.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

340B (no specific bill), National Diabetes Clinical Care Commission Act (H.R. 1074, S.539), Eliminating Disparities in Diabetes Prevention Act (H.R. 3322), Oncology education (no specific bill), adult vaccine policies (no specific bill), medication adherence, DISARM (H.R. 4187), ACA Implementation (no specific bill), Hepatitis C education (no specific bill), HIV education (no specific bill), MODDERN Cures Act of 2013 (H.R. 3116),Prescription Drug User Fee Act (general planning), 21st Century Cures (no specific bill), Strengthening Medicare Anti-Fraud Measures Act of 2013 (H.R. 2925), Big data (general education), Alzheimer's education (no specific bill), biosimilars (general education, no specific bill), general pharmaceutical industry issues and education.

Client expense: $1,160,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Implementation of the Affordable Care Act of 2010 (Pub. L. 111-148) Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152) Implementation of the Food and Drug Administration Safety and Innovation Act (FDASIA) Pub.L. 112-144) H.R. 1919 the Safeguarding America's Pharmaceuticals Act of 2013 H.R. 3742, Antibiotic Development to Advance Patient Treatment (ADAPT) Act H.R. 4187, Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act

Client expense: Not reported · Firm income: $54,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Implementation of the "GAIN" provisions/Title VIII of the Food and Drug Administration Safety and Innovation Act (FDASIA) - PL 112-144; antibiotic product development incentive, limited population antibiotic product (LPAD) and breakpoint legislation HR 3742 -- the Antibiotic Development to Advance Patient Treatment Act of 2013 H.R.4187 -- Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2014 antibiotic product incentives for possible inclusion in the House "21st Century Cures" effort

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 4302 Protecting Access to Medicare Act of 2014 - Public Law No: 113-93 In the above the specific issues included potential Medicare offsets that might be applied to prescription drugs H.R.4187 -- Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2014

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Ongoing discussions surrounding next steps for protecting and promoting incentives for the development of resistant pathogens including breakpoints Antibiotic resistance Reimbursement issues for antibiotics H.R. 4187, DISARM - Developing An Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2014 Presidents Council of Advisors on Science and Technology (PCAST) and their recent report on antibiotic resistance LDAD (Limited Population Antibacterial Drug) proposal

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

Government targets: SENATE

H.R. 351 - Protecting Seniors' Access to Medicare Act of 2013; provisions related to the Independent Payment Advisory Board H.R. 928 - Medicare Prescription Drug Savings and Choice Act of 2013; provisions related to Medicare Part D H.R. 1024 - Medication Therapy Empowerment Act of 2013; provisions related to Part D issues H.R. 1102 - Medicare Prescription Drug Price Negotiation Act of 2013; Provisions related to Part D issues and non-interference H.R. 1588 - Medicare Drug Savings Act of 2013; provisions related to Part D issues H.R. 2810 - Medicare Patient Access and Quality Improvement Act of 2013; Provisions related to SGR reform H.R. 2827 - To amend title XVIII of the Social Security Act to allow for fair application of the exceptions process for drugs in tiers in formularies in prescription drug plans under Medicare part D; provisions related to Medicare Part D Drug Tier Formularies H.R. 3890 - Better Care, Lower Cost Act; Provisions related to Part D, value-based insurance design, and chronic disease H.R 4160 - Keep the Promise to Seniors Act of 2014; provisions related to Part D H.R. 4187 - Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act H.R. 4302 - Protecting Access to Medicare Act of 2014 - provisions related to the biopharmaceutical industry S. 117 - Medicare Prescription Drug Price Negotiation Act of 2013; provisions related to Part D issues S. 351 - Protecting Seniors' Access to Medicare Act of 2013; provisions related to the Independent Payment Advisory Board S. 408 - Medicare Prescription Drug Savings and Choice Act of 2013; provisions related to Medicare Part D S. 557 - Medication Therapy Empowerment Act of 2013; provisions related to Part D issues S. 740 - Medicare Drug Savings Act of 2013; provisions related to Part D issues S. 1871 - SGR Repeal and Medicare Beneficiary Access Act of 2013; Provisions related to reforming Medicare physician payments S. 1932 - Better Care, Lower Cost Act; Provisions related to Part D, value-based insurance design, and chronic disease S. 2000 - SGR Repeal and Medicare Provider Payment Modernization Act of 2014; Provisions related to SGR reform S. 2110 - Medicare SGR Repeal and Beneficiary Access Improvement Act of 2014; Provisions related to SGR reform No bill # assigned - Contract Year 2015 Policy and Technical Cganges to the Medicare Advantage and the Medicare Prescription Drug Benefits ProgramsProvisions related to Part D No bill # assigned - Proposals to increase co-payments for Part D beneficiaries receiving the low-income subsidy No bill # assigned - Issues related to better use of medicines and comprehensive medication management No bill # assigned - Medicaid Program, Covered Outpatient Drugs rulemaking No bill # assigned - Implementation Issues relating to the Physician Payment Sunshine Act No bill # assigned - Vaccine access and coverage issues

Client expense: $1,140,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)

H. Con. Res. 96, Establishing the budget for the United States Government for fiscal year 2015 and setting forth appropriate budgetary levels for fiscal years 2016 through 2024, (potential provisions relating to Medicare Part D and the establishment of a Medicaid style "rebate"). S. 2110, Medicare SGR Repeal and Beneficiary Access Improvement Act (potential revenue raising provisions).Potential deficit reduction legislation that might include provisions to reduce Medicare Part B reimbursements for drugs and biologics. H.R.1588, Medicare Drug Savings Act of 2013 (provisions relating to Medicare Part D and the establishment of a Medicaid style mandatory rebate on prescription drugs). H.R. 4302, Protecting Access to Medicare Act of 2014, (potential revenue raising provisions). H.R. 4187, Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2014

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicare Physician Payment Reform; in general. H.R. 4015/S. 2000, the SGR Repeal and Medicare Provider Payment Modernization Act of 2014; all provisions. S. 2110, the Medicare SGR Repeal and Beneficiary Access Improvement Act of 2014; all provisions. S. 2122, the Responsible Medicare SGR Repeal and Beneficiary Access Improvement Act of 2014; all provisions. S. 2157, the Commonsense Medicare SGR Repeal and Beneficiary Access Improvement Act of 2014; all provisions. H.R. 4302, the Protecting Access to Medicare Act of 2014; all provisions. Audiology-related legislation; in general. H.R. 2330, the Medicare Audiology Services Enhancement Act of 2013; all provisions. H.R. 4035/S. 2046, the Access to Hearing Healthcare Act of 2014; all provisions. H.R. 351/S. 351, the Protecting Seniors' Access to Medicare Act of 2013 and repeal of the Independent Payment Advisory Board (IPAB); in general. Issues regarding Medicare appeals backlog; in general. Compliance with the Medicare and Medicaid Electronic Health Record (EHR) Incentive Program; in general. Standards for electronic health record (EHR) Meaningful Use; in general. Comments on final 2014 Medicare Physician Fee Schedule rule; in general. Support for increased transparency at CMS to ensure that the rulemaking process for changes to the Medicare physician fee schedule under the misvalued codes initiative is transparent and allows for sufficient input by stakeholders well before the new values are implemented. H.R. 4695, a bill to amend XVIII of the Social Security Act to add sleep apnea screening to the initial preventative physicial examination under the Medicare program; all provisions. Comments re: CMS' final rule entitled Medicare and Medicaid Programs; Regulatory Provisions To Promote Program Efficiency, Transparency, and Burden Reduction; Part II [CMS-3267-F] relating to the Medicare hospital Conditions of Participation (CoPs). H.R. 4187, legislation to modify the current Medicare New Technology Add-on Payment (NTAP) Program to provide a new supplemental payment for certain antimicrobial drugs used in the hospital setting. H.R.5304, the Audiology Patient Choice Act of 2014; all provisions. Concerns pertaining to implementation of the Physician Payments Sunshine Act (Sunshine Act) and subsequent requests for an expanded timeframe to allow recipients to register, review, and dispute their data in the Open Payments System before publication. Support for additional transparency and comment opportunity in the valuation of physician and other healthcare professional services re: Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule, Clinical Laboratory Fee Schedule, Access to Identifiable Data for the Centers for Medicare & Medicaid Innovation Models & Other Revisions to Part B for CY 2015 - Proposal to Modify the Process for Establishing Values for New, Revised and Potentially Misvalued Codes. Comments re: the "Medicare Program; End-Stage Renal Disease Prospective Payment System, Quality Incentive Program, and Durable Medical Equipment, Prosthetics, Orthotics, and Supplies" published in the Federal Register as a proposed notice on July 11, 2014; provisions relating to the revision of the hearing aid exclusion to encompass osseointegrated implants and all other bone conducting prosthetics. Comments on the Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule, Clinical Laboratory Schedule & Other Revisions to Part B for CY 2015 published in the Federal Register as a proposed notice on July 11, 2014. Provisions relating to: (1) Sustainable Growth Rate (SGR); (2) Resource Based Practice Expense (PE) Relative Value Units (RVUs); (3) Potentially Misvalued Services Under the Fee Schedule; (4) Validating RVUs of Services; (5) Payment for Secondary Interpretation of Images; (6) Physician Compare Website; (7) Electronic Health Records (EHR) Meaningful Use (MU) Incentive Program; (8) Physician Quality Reporting System; and (9) Value Based Payment Modifier and Physician Feedback Program.

Client expense: $178,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), General Services Administration (GSA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA)

Implementation issues related to the Pharmaceutical Quality, Security, and Accountability Act (P.L. 113-54), the Patient Protection and Affordable Care Act (P.L. 111-148) and the Food and Drug Administration Safety and Innovation Act (P.L. 112-144). H.R.4187, DISARM Act of 2014. Issues related to health care and the Food and Drug Administration (FDA). Issues related to the 340B Program.

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

Government targets: Agriculture, Dept of (USDA), HOUSE OF REPRESENTATIVES, SENATE

Health care reform implementation; the 340B program of the Health Resources and Services Administration (HRSA), specifically 340B drug pricing program issues, including program expansion and specific issues include: HRSA oversight, definition of patient, the Affordable Care Act's expansion of covered 340B entities. Support legislation increasing access to wireless technologies. FDA review process consistency and predictability. Address concerns with Medicare Independent Payment Advisory Board (IPAB).Address concerns with changes to Medicare Part B and Part D programs. Issues related to antibiotics and breakpoints. Ongoing discussions surrounding next steps for protecting and promoting incentives for the development of resistant pathogens including breakpoints; antibiotic resistance among elderly population; reimbursement issues for antibiotics. H.R. 4187, DISARM - Developing An Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2014; President's Council of Advisors on Science and Technology (PCAST) and their recent report on antibiotic resistance.

Client expense: $450,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Implementation of the "GAIN" provisions/Title VIII of the Food and Drug Administration Safety and Innovation Act (FDASIA) - PL 112-144; antibiotic product development incentive, limited population antibiotic product (LPAD) and breakpoint legislation; HR 3742- the Antibiotic Development to Advance Patient Treatment Act of 2013; H.R. 4187 - Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2014;antibiotic product incentives for possible inclusion in the House "21st Century Cures" effort

Client expense: $450,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE