To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models.

21st Century Cures Act 2.0 ---RFI from House Energy and Commerce Committee Coronavirus (COVID-19) Pandemic ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.5076/S.1872: Protecting Seniors through Immunizations Act of 2019 ---H.R.7288: The Taxpayer Research and Coronavirus Knowledge (TRACK) Act ---COVID-19 Vaccine and Therapeutic Development ---Home Administration of Part B Drugs ---Patient Cost-Sharing and Smoothing ---Pricing-related Provisions Drug Pricing ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.1093/S.378: Stop Price Gouging Act of 2019 ---H.R.2376/S.1227: Prescription Pricing for the People Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7288: The Taxpayer Research and Coronavirus Knowledge (TRACK) Act ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---CMMI Authority ---General ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Implementation of CREATES Act of 2019 ---International Pricing Index Proposal ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Potential Administration Executive Orders ---Pricing-related Provisions Medicaid ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Alternative payment arrangements for gene therapies ---Average Manufacturer Price Calculations ---Pricing and Rebates Medicare Expansion ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 Reimbursement and Coverage of Innovative Products ---H.R.5122: To prohibit further action on the proposed rule regarding testing of Medicare Part B Prescription Drug Models ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---S.2326: New Opportunities for Value that Extend Lives (NOVEL) Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Administration Rebate Rule ---CMMI Authority ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Home Administration of Part B Drugs ---International Pricing Index Proposal ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Surprise Billing ---Value-based Contracting and Communications Vaccines and Infectious Diseases ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.5076/S.1872: Protecting Seniors through Immunizations Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020

Client expense: $3,320,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

21st Century Cures Act 2.0 ---RFI from House Energy and Commerce Committee 340B Drug Discount Program ---340B Pause Act (Discussion Draft House/Senate) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Nonfunding) ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Executive Order on Modernizing Influenza Vaccines ---Gene editing ---Implementation of 21st Century Cures Act of 2016 ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---National Biodefense Strategy ---Tropical Disease Priority Review Voucher (PRV) Program Biosimilars ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---Biosimilar Copay ---Brazil Biologics Regulations ---BSUFA ---Canada Biologics Regulations ---Coding ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2017 ---Implementation of CREATES Act of 2019 ---India Biologics Regulations ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---Reimbursement Climate Change ---RFI from House Select Committee on the Climate Crisis Coronavirus (COVID-19) Pandemic ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.5076/S.1872: Protecting Seniors through Immunizations Act of 2019 ---H.R.6206: Pandemic Response and Emergency Preparedness (PREP) Act of 2020 ---H.R.6260/S.3545: Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Coronavirus Patients Act of 2020 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7288: The Taxpayer Research and Coronavirus Knowledge (TRACK) Act ---COVID-19 Vaccine and Therapeutic Development ---Drug Supply Chain Management ---Healthcare Disparities ---Home Administration of Part B Drugs ---Liability ---Medicare reimbursement policies ---Patient Cost-Sharing and Smoothing ---Pricing-related Provisions ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Senate HELP Pandemic Preparedness White Paper Drug Evaluation and Review ---S.1617: Second Look at Drug Patents Act of 2019 ---S.3872: Promising Pathway Act ---Compassionate Use/Expanded Access ---Expedited Pathways ---Priority Review Voucher Programs Drug Manufacturing, Quality & Distribution ---Drug Shortages ---Drug Supply Chain Management Drug Patenting ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 Drug Pricing ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.1093/S.378: Stop Price Gouging Act of 2019 ---H.R.1425: The Patient Protection and Affordable Care Enhancement Act of 2020 ---H.R.2069/S.474: Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 ---H.R.2113: Prescription Drug STAR Act of 2019 ---H.R.2376/S.1227: Prescription Pricing for the People Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7288: The Taxpayer Research and Coronavirus Knowledge (TRACK) Act ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---CMMI Authority ---General ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Implementation of CREATES Act of 2019 ---International Pricing Index Proposal ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Potential Administration Executive Orders ---Pricing-related Provisions Foreign Drug Data Protection Laws ---Regulatory Harmonization Funding for Antimicrobial Resistance Programs ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Health Defense Operations Funding Designation ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for FDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 Funding for Health Resources and Services Administration (HRSA) - Vaccine Injury Compensation Program (VICP) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for National Institutes of Health ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Funding for 2020-21 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Medicaid ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Alternative payment arrangements for gene therapies ---Average Manufacturer Price Calculations ---Pricing and Rebates Medicare Expansion ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 Orphan Drug Issues ---H.R.4439/S.4010: Creating Hope Reauthorization Act of 2019 ---H.R.4712: Fairness in Orphan Drug Exclusivity Act of 2019 ---Tax Credit Rare Pediatric Disease Priority Review ---H.R.4439/S.4010: Creating Hope Reauthorization Act of 2019 Reimbursement and Coverage of Innovative Products ---H.R.275: Medicare Prescription Drug Price Negotiation Act of 2019 ---H.R.5122: To prohibit further action on the proposed rule regarding testing of Medicare Part B Prescription Drug Models ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---S.2326: New Opportunities for Value that Extend Lives (NOVEL) Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Administration Rebate Rule ---CMMI Authority ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Home Administration of Part B Drugs ---International Pricing Index Proposal ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Surprise Billing ---Value-based Contracting and Communications The United States-Mexico-Canada Agreement (USMCA) ---Implementation of United States-Mexico-Canada Agreement (USMCA) ---IP Provisions Trade and Foreign Drug Price Controls US-China Trade Agreement ---IP Provisions US-EU Trade Agreement ---IP Provisions US-Japan Trade Agreement ---IP Provisions US-Kenya Trade Agreement ---IP Provisions US-UK Trade Agreement ---IP Provisions Vaccines and Infectious Diseases ---H.R.2862/S.1619: Vaccine Awareness Campaign to Champion Immunization Nationally and Enhance Safety (VACCINES) Act of 2019 ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.5076/S.1872: Protecting Seniors through Immunizations Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Adult Immunization Education ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Maternal Immunization ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program

Client expense: $3,320,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

S. 1465 / HR 2799: Furthering Access to Stroke Telemedicine (FAST) Act S. 2484 / HR 4442: CONNECT for Health Act; Section 303 S.3504: CHRONIC Care Act of 2016 HR 2948: Medicare Telehealth Parity Act of 2015, Section 105(a)(1) HR 5122: To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models. Preservation of the in-office ancillary exception to the Stark law; urging changes to the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 1465 / HR 2799: Furthering Access to Stroke Telemedicine (FAST) Act S. 2484 / HR 4442: CONNECT for Health Act; Section 303 HR 2948: Medicare Telehealth Parity Act of 2015, Section 105(a)(1) HR 5122: To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models. Preservation of the in-office ancillary exception to the Stark law; urging changes to the Meaningful Use Program and Medicare Access and CHIP Reauthorization Act of 2015 (MACRA).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 2511: Improving Health Information Technology Act S. 1465 / HR 2799: Furthering Access to Stroke Telemedicine (FAST) Act S. 2484: HR 4442: CONNECT for Health Act; Section 303 S. 2978: Protect Continuing Physician Education and Patient Care Act HR 2948: Medicare Telehealth Parity Act of 2015, Section 105(a)(1) HR 5122: To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models. Preservation of the in-office ancillary exception to the Stark law; urging changes to the Meaningful Use Program and Medicare Access and CHIP Reauthorization Act of 2015 (MACRA).

Client expense: $280,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Medicare Payment Advisory Commission (MedPAC), SENATE

Monitor legislative and administrative action related to Medicare policy. Monitor legislative and administrative action related to sustainable growth rate, SGR fix, and SGR repeal. Monitor enforcement of Medicares imaging equipment preventative maintenance policy. Monitor legislative and administrative action related to Medicare's 2011 guidance on servicing hospital equipment, including medical imaging equipment. S. 148, Medicare DMEPOS Competitive Bidding Improvement Act of 2015. H.R. 2, Medicare Access and CHIP Reauthorization Act of 2015. H.R. 5122, To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models.

Client expense: $1,880,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR), White House Office

Monitor legislative and administrative action related to Medicare policy. Monitor legislative and administrative action related to sustainable growth rate, SGR fix, and SGR repeal. Monitor enforcement of Medicares imaging equipment preventative maintenance policy. Monitor legislative and administrative action related to Medicare's 2011 guidance on servicing hospital equipment, including medical imaging equipment. S. 148, Medicare DMEPOS Competitive Bidding Improvement Act of 2015. H.R. 2, Medicare Access and CHIP Reauthorization Act of 2015. H.R. 5122, To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models.

Client expense: $2,260,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR), White House Office

Anti-poverty legislation HR 5122- CMS' Medicare Part B proposed regulation FY 2017 Appropriations HJ Res 1, 2, 7, 12, 28, 41 and related bills- Constitutional Balanced Budget Amendment S 3040, HR 5926- Labor, Health, Human Services, Education Appropriations HR 2028- Continuing Appropriations and Military Construction, Veterans Affairs and Related Agencies Appropriations Act, and Zika Response and Preparedness Act

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

Government targets: Equal Employment Opportunity Commission (EEOC), HOUSE OF REPRESENTATIVES, Labor, Dept of (DOL), SENATE, Social Security Administration (SSA), Substance Abuse & Mental Health Services Administration (SAMHSA), Treasury, Dept of, White House Office

HR 34- Helping Families in Mental Health Crisis Act 1115 Waivers for behavioral healthcare Anti-poverty legislation HR 5122- CMS' Medicare Part B proposed regulation S 2579- Funding for water infrastructure and other aid to address lead crisis in Flint, MI Price gouging by pharmaceutical companies Repeal of the Affordable Care Act and cuts to Medicare and Medicaid Federal income tax exclusion for employer-sponsored health care HR 2050, HR 879, S 2045, S 2075- Federal 40% tax on high-cost employer-sponsored health benefits Children's Health Insurance Program (CHIP) Parity for Puerto Rico Medicaid Funding

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

Government targets: Equal Employment Opportunity Commission (EEOC), HOUSE OF REPRESENTATIVES, Labor, Dept of (DOL), SENATE, Social Security Administration (SSA), Substance Abuse & Mental Health Services Administration (SAMHSA), Treasury, Dept of, White House Office

Monitor implementation of the Patient Protection and Affordable Care Act (P.L. 111-148). Monitor federal and legislative activity related to Medicare Reimbursement. Monitor federal issues and legislation associated with health care policy. Monitor implementation of Medicare Access and CHIP Reauthorization Act of 2015 (P.L. 114-10). H.R. 34, 21st Century Cures Act (P.L. 114-255) H.R. 270, Flexibility in Health IT Reporting (Flex-IT) Act of 2015. H.R.775, Medicare Access to Rehabilitation Services Act of 2015. H.R. 1600, Patients' Access to Treatments Act of 2015. H.R. 3309, Flex-IT 2 Act. H.R. 4227, Medicare Advantage Bill of Rights. H.R. 4848, HIP Act. H.R. 4909, National Defense Authorization Act for Fiscal Year 2017. H.R. 5001, Flexibility in Electronic Health Record Reporting Act. H.R. 5122, To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models. H.R. 5293, Department of Defense Appropriations, FY 2017. H.R. 5652, Access to Better Care Act of 2016 H.R. 5573, PRICED Act H.R. 5926, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations, FY 2017. S.539, Medicare Access to Rehabilitation Services Act of 2015. S. 2392, Medicare Advantage Bill of Rights. S. 2511, Improving Health Information Technology Act. S. 2822, Flexibility in Electronic Health Record Reporting Act S. 2943, National Defense Authorization Act for Fiscal Year 2017 S. 3000, Department of Defense Appropriations, FY 2017. S. 3040, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations, FY 2017. S. 3094, PRICED Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Monitor implementation of the Patient Protection and Affordable Care Act (P.L. 111-148). Monitor federal and legislative activity related to Medicare Reimbursement. Monitor federal issues and legislation associated with health care policy. Monitor implementation of Medicare Access and CHIP Reauthorization Act of 2015 (P.L. 114-10). H.R. 34, 21st Century Cures Act (P.L. 114-255) H.R. 270, Flexibility in Health IT Reporting (Flex-IT) Act of 2015. H.R.775, Medicare Access to Rehabilitation Services Act of 2015. H.R. 1600, Patients' Access to Treatments Act of 2015. H.R. 3309, Flex-IT 2 Act. H.R. 4227, Medicare Advantage Bill of Rights. H.R. 4848, HIP Act. H.R. 4909, National Defense Authorization Act for Fiscal Year 2017. H.R. 5001, Flexibility in Electronic Health Record Reporting Act. H.R. 5122, To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models. H.R. 5293, Department of Defense Appropriations, FY 2017. H.R. 5652, Access to Better Care Act of 2016 H.R. 5573, PRICED Act H.R. 5926, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations, FY 2017. S.539, Medicare Access to Rehabilitation Services Act of 2015. S. 2392, Medicare Advantage Bill of Rights. S. 2511, Improving Health Information Technology Act. S. 2822, Flexibility in Electronic Health Record Reporting Act S. 2943, National Defense Authorization Act for Fiscal Year 2017 S. 3000, Department of Defense Appropriations, FY 2017. S. 3040, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations, FY 2017. S. 3094, PRICED Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Potential pharmaceutical reimbursement cuts (offsets) and potential inclusion of Medicare coverage of FDA-approved obesity drugs. H.R. 2404/S 1509 - Treat and Reduce Obesity Act of 2015 HR 5122 - To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models. Revisions to Medicare reimbursement programs, including CMMI demonstration proposals

Client expense: $470,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Monitor implementation of the Patient Protection and Affordable Care Act (P.L. 111-148). Monitor federal and legislative activity related to Medicare Reimbursement. Monitor federal issues and legislation associated with health care policy. Monitor implementation of Medicare Access and CHIP Reauthorization Act of 2015 (P.L. 114-10). H.R. 34, 21st Century Cures Act (P.L. 114-255) H.R. 270, Flexibility in Health IT Reporting (Flex-IT) Act of 2015. H.R.775, Medicare Access to Rehabilitation Services Act of 2015. H.R. 1600, Patients' Access to Treatments Act of 2015. H.R. 3309, Flex-IT 2 Act. H.R. 4227, Medicare Advantage Bill of Rights. H.R. 4848, HIP Act. H.R. 4909, National Defense Authorization Act for Fiscal Year 2017. H.R. 5001, Flexibility in Electronic Health Record Reporting Act. H.R. 5122, To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models. H.R. 5293, Department of Defense Appropriations, FY 2017. H.R. 5652, Access to Better Care Act of 2016 H.R. 5573, PRICED Act H.R. 5926, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations, FY 2017. S.539, Medicare Access to Rehabilitation Services Act of 2015. S. 2392, Medicare Advantage Bill of Rights. S. 2511, Improving Health Information Technology Act. S. 2822, Flexibility in Electronic Health Record Reporting Act S. 2943, National Defense Authorization Act for Fiscal Year 2017 S. 3000, Department of Defense Appropriations, FY 2017. S. 3040, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations, FY 2017. S. 3094, PRICED Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Monitor implementation of the Patient Protection and Affordable Care Act (P.L. 111-148). Monitor federal and legislative activity related to Medicare Reimbursement. Monitor federal issues and legislation associated with health care policy. Monitor implementation of Medicare Access and CHIP Reauthorization Act of 2015 (P.L. 114-10). H.R. 34, 21st Century Cures Act (P.L. 114-255) H.R. 270, Flexibility in Health IT Reporting (Flex-IT) Act of 2015. H.R.775, Medicare Access to Rehabilitation Services Act of 2015. H.R. 1600, Patients' Access to Treatments Act of 2015. H.R. 3309, Flex-IT 2 Act. H.R. 4227, Medicare Advantage Bill of Rights. H.R. 4848, HIP Act. H.R. 4909, National Defense Authorization Act for Fiscal Year 2017. H.R. 5001, Flexibility in Electronic Health Record Reporting Act. H.R. 5122, To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models. H.R. 5293, Department of Defense Appropriations, FY 2017. H.R. 5652, Access to Better Care Act of 2016 H.R. 5573, PRICED Act H.R. 5926, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations, FY 2017. S.539, Medicare Access to Rehabilitation Services Act of 2015. S. 2392, Medicare Advantage Bill of Rights. S. 2511, Improving Health Information Technology Act. S. 2822, Flexibility in Electronic Health Record Reporting Act S. 2943, National Defense Authorization Act for Fiscal Year 2017 S. 3000, Department of Defense Appropriations, FY 2017. S. 3040, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations, FY 2017. S. 3094, PRICED Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Part D drug coverage and patient access issues and policy ESRD bundling and drug reimbursement issues HCPCS coding and reimbursement decisions Implementation of Patient Protection & Affordable Health Care Act (P.L. 111-148) and Implementation of Health Care and Education Reconciliation Act (P.L. 111-152) Least costly alternative (LCA) policy Changes re: Medicare Part B and Average Sales Price Medicare secondary payor for ESRD services Extension of rebates on Medicare Part D drugs Performance measures for bone and mineral metabolism for ESRD program Implementation of American Taxpayer Relief Act of 2012 H.R. 1416, Cancer Patient Protection Act of 2015 21st Century Cures/Innovation initiatives, including H.R. 6, 21st Century Cures Act S. 506, To amend Part B of title XVIII of the Social Security Act to exclude customary prompt pay discounts from manufacturers to wholesalers from the average sales price for drugs and biologicals under Medicare, and for other purposes H.R. 696, To amend part B of title XVIII of the Social Security Act to exclude customary prompt pay discounts from manufacturers to wholesalers from the average sales price for drugs and biologicals under Medicare, and for other purposes Medicaid drug rebate, drug coverage and patient access to therapies issues and policy S. 31, Medicare Prescription Drug Price Negotiation Act of 2015 H.R. 1130, Chronic Kidney Disease Improvement in Research and Treatment Act of 2015 S. 598, Chronic Kidney Disease Improvement in Research and Treatment Act of 2015 S. 648, Medicare Formulary Improvement Act of 2015 H.R. 2, Medicare Access and CHIP Reauthorization Act of 2015 H.R.2570, Strengthening Medicare Advantage through Innovation and Transparency for Seniors of 2015 H.R. 5122, To prohibit further action on the proposed rule regarding testing of Medicare Part B Prescription Drug Models

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

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

Medicare Program; Part B Drug Payment Model, Proposed rule, CMS-1670-P (March 11, 2016) - Provisions related to the Medicare Part B Drug Payment Model Medicaid Program: Covered Outpatient Drugs (CMS-2345-FC) - Provisions related to line extension drug definition, effective date and other issues Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule (CMS-1654-P) - Expansion of Medicare Diabetes Prevention Program Model S. 31: Medicare Prescription Drug Price Negotiation Act of 2015 - Provisions related to Secretary negotiation authority in Part D program S. 141: Protecting Seniors' Access to Medicare Act of 2015 - Provisions related to Independent Payment Advisory Board (IPAB) repeal S. 648: Medicare Formulary Improvement Act of 2015 - Provisions related to codification of six protected classes in Part D program S. 1083: Medicare Drug Savings Act of 2015 - Provisions related to drug rebates in Medicare Part D S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to Secretary negotiation authority in Part D program, Medicare and Medicaid rebates, resolution of government enforcement actions, and reporting of certain drug manufacturer expenditures S. 2981: A bill to amend title XIX of the Social Security Act to add standards for drug compendia for physician use for purposes of Medicaid payment for certain drugs, and for other purposes H.R. 22: FAST Act - Medicare related offsets to the biopharmaceutical industry H.R. 1190: Protecting Seniors Access to Medicare Act of 2015 - Provisions related to IPAB repeal H.R. 2005: Medicare Drug Savings Act of 2015 - Provisions related to changes to Part D rebates H.R. 3513: Prescription Drug Affordability Act of 2015 - Provisions related to Secretary negotiation authority in Part D program, Medicare and Medicaid rebates, resolution of government enforcement actions, and reporting of certain drug manufacturer expenditures H.R. 5122: To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models - Suspending the Part B Drug Payment Model Proposed Medicare hospital outpatient prospective payment system (OPPS) rule for 2016 (CMS-1656-P) Department of Health and Human Services (HHS) delivery system reform issues and regulatory barriers to innovation Medicare Part B Average Sales Price (ASP) policy issues Medicare Part D rebates policy issues Drug cost and pricing policy issues Transparency policy issues Alternative payment models policy issues Value-based arrangements policy issues Coding and reimbursement policy issues including for biologics Prescription drug abuse policy issues Center for Medicare and Medicaid Innovation (CMMI) transparency and other policy issues MedPAC June Report - Part B and D policy issues Medicaid rebates/reformulations policy issues Non-interference policy issues

Client expense: $492,000 · 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), SENATE, U.S. Trade Representative (USTR)

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. 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. 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. 1270 - Restoring Access to Medication and Improving Health Savings Act of 2016 - FSA and HSA use for over the counter medication 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. 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 - age requirement for purchase of OTC medication including dextromethorphan Monograph reform 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: $492,000 · 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), SENATE, U.S. Trade Representative (USTR)

Medicare Program; Part B Drug Payment Model, Proposed rule, CMS-1670-P (March 11, 2016) - Provisions related to the Medicare Part B Drug Payment Model Medicaid Program: Covered Outpatient Drugs (CMS-2345-FC) - Provisions related to line extension drug definition, effective date and other issues Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule (CMS-1654-P) - Expansion of Medicare Diabetes Prevention Program Model S. 31: Medicare Prescription Drug Price Negotiation Act of 2015 - Provisions related to Secretary negotiation authority in Part D program S. 141: Protecting Seniors' Access to Medicare Act of 2015 - Provisions related to Independent Payment Advisory Board (IPAB) repeal S. 648: Medicare Formulary Improvement Act of 2015 - Provisions related to codification of six protected classes in Part D program S. 1083: Medicare Drug Savings Act of 2015 - Provisions related to drug rebates in Medicare Part D S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to Secretary negotiation authority in Part D program, Medicare and Medicaid rebates, resolution of government enforcement actions, and reporting of certain drug manufacturer expenditures H.R. 22: FAST Act - Medicare related offsets to the biopharmaceutical industry H.R. 1190: Protecting Seniors Access to Medicare Act of 2015 - Provisions related to IPAB repeal H.R. 2005: Medicare Drug Savings Act of 2015 - Provisions related to changes to Part D rebates H.R. 3513: Prescription Drug Affordability Act of 2015 - Provisions related to Secretary negotiation authority in Part D program, Medicare and Medicaid rebates, resolution of government enforcement actions, and reporting of certain drug manufacturer expenditures H.R. 5122: To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models - Suspending the Part B Drug Payment Model Department of Health and Human Services (HHS) delivery system reform issues and regulatory barriers to innovation Medicare Part B Average Sales Price (ASP) policy issues Medicare Part D rebates policy issues Drug cost and pricing policy issues Transparency policy issues Alternative payment models policy issues Value-based arrangements policy issues Coding and reimbursement policy issues including for biologics Prescription drug abuse policy issues Center for Medicare and Medicaid Innovation (CMMI) transparency and other policy issues MedPAC June Report - Part B and D policy issues Medicaid rebates/reformulations policy issues Non-interference 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. 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)

HR 5122, legislation to prohibit further action on the Centers for Medicare & Medicaid Services (CMS) proposed rule for the Medicare Part B Drug Demo H.R. 5001/S.2822, the Flexibility in Electronic Health Record (EHR) Reporting Act HR 1416 The Cancer Patient Protection Act of 2015 Implementation of the Medicare Access and CHIP Reauthorization Act of 2015

Client expense: $65,519 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicare Part D (general education, no specific bill), changes to low-income subsidy structure in Medicare Part D (general education, no specific bill), H.R. 5122 (Centers for Medicare and Medicaid Innovation Part B demo), Independent Payment Advisory Board (general education, no specific bill), Medicare Part B (general education); Medicaid (no specific bill)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Monitor federal issues and legislation related to healthcare policy. Monitor federal issues and legislation related to Medicare reimbursement. Monitor implementation of Medicare Access and CHIP Reauthorization Act of 2015 (P.L. 114-10). Monitor implementation of the Patient Protection and Affordable Care Act (P.L. 111-148). Extend Section 3111, P.L. 111-148. Monitor the implementation of Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act, 2017, and Zika Response and Preparedness Act (P.L. 114-223). H.R. 6, House 21st Century Cures Act. H.R. 270, Flexibility in Health IT Reporting (Flex-IT) Act of 2015. H.R.775, Medicare Access to Rehabilitation Services Act of 2015. H.R. 1600, Patients' Access to Treatments Act of 2015. H.R. 1725, National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015. H.R. 1859, Ensuring Children's Access to Specialty Care Act of 2015. H.R. 2256, Veterans Information Modernization Act. H.R. 2464, Demanding Accountability for Veterans Act of 2015. H.R. 3020, House Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2015. H.R. 3309, Flex-IT 2 Act H.R. 4227, Medicare Advantage Bill of Rights. H.R. 4848, HIP Act H.R. 4909, National Defense Authorization Act for Fiscal Year 2017 H.R. 5001, Flexibility in Electronic Health Record Reporting Act. H.R. 5122, To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models. H.R. 5293, Department of Defense Appropriations, FY 2017. H.R.5721, Local Coverage Determination Clarification Act S. 480, National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015. S.539, Medicare Access to Rehabilitation Services Act of 2015. S. 2392, Medicare Advantage Bill of Rights. S. 2511, Improving Health Information Technology Act. S. 2822, Flexibility in Electronic Health Record Reporting Act S. 2943, National Defense Authorization Act for Fiscal Year 2017 S. 2978, The Protect Continuing Physician Education and Patient Care Act. S. 3000, Department of Defense Appropriations, FY 2017. S. 3040, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations, FY 2017. S.3173, EHR Regulatory Relief Act. Senate 21st Century Cures Act counterpart package, including S. 2700, S.185, S.2713, S.2745, S.2742, S.1878, S.1077, S.1101, S.2055, S.1767, S.1597, S.2512, S.2030, S.1622, S.2014, S.800, S.849, S.2503, and S.2511. Funding for NIH, CDC, DOD, related to arthritis and rheumatic disease research and education. Funding for Pediatric Subspecialty Loan Repayment Program. Draft, House Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations, FY 2017.

Client expense: $110,000 · Firm income: Not reported

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

Monitor federal issues and legislation related to healthcare policy. Monitor federal issues and legislation related to Medicare reimbursement. Monitor implementation of Medicare Access and CHIP Reauthorization Act of 2015 (P.L. 114-10). Monitor implementation of the Patient Protection and Affordable Care Act (P.L. 111-148). Extend Section 3111, P.L. 111-148. Monitor the implementation of Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act, 2017, and Zika Response and Preparedness Act (P.L. 114-223). H.R. 6, House 21st Century Cures Act. H.R. 270, Flexibility in Health IT Reporting (Flex-IT) Act of 2015. H.R.775, Medicare Access to Rehabilitation Services Act of 2015. H.R. 1600, Patients' Access to Treatments Act of 2015. H.R. 1725, National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015. H.R. 1859, Ensuring Children's Access to Specialty Care Act of 2015. H.R. 2256, Veterans Information Modernization Act. H.R. 2464, Demanding Accountability for Veterans Act of 2015. H.R. 3020, House Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2015. H.R. 3309, Flex-IT 2 Act H.R. 4227, Medicare Advantage Bill of Rights. H.R. 4848, HIP Act H.R. 4909, National Defense Authorization Act for Fiscal Year 2017 H.R. 5001, Flexibility in Electronic Health Record Reporting Act. H.R. 5122, To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models. H.R. 5293, Department of Defense Appropriations, FY 2017. H.R.5721, Local Coverage Determination Clarification Act S. 480, National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015. S.539, Medicare Access to Rehabilitation Services Act of 2015. S. 2392, Medicare Advantage Bill of Rights. S. 2511, Improving Health Information Technology Act. S. 2822, Flexibility in Electronic Health Record Reporting Act S. 2943, National Defense Authorization Act for Fiscal Year 2017 S. 2978, The Protect Continuing Physician Education and Patient Care Act. S. 3000, Department of Defense Appropriations, FY 2017. S. 3040, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations, FY 2017. S.3173, EHR Regulatory Relief Act. Senate 21st Century Cures Act counterpart package, including S. 2700, S.185, S.2713, S.2745, S.2742, S.1878, S.1077, S.1101, S.2055, S.1767, S.1597, S.2512, S.2030, S.1622, S.2014, S.800, S.849, S.2503, and S.2511. Funding for NIH, CDC, DOD, related to arthritis and rheumatic disease research and education. Funding for Pediatric Subspecialty Loan Repayment Program. Draft, House Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations, FY 2017.

Client expense: $110,000 · Firm income: Not reported

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

Monitor federal issues and legislation related to healthcare policy. Monitor federal issues and legislation related to Medicare reimbursement. Monitor implementation of Medicare Access and CHIP Reauthorization Act of 2015 (P.L. 114-10). Monitor implementation of the Patient Protection and Affordable Care Act (P.L. 111-148). Extend Section 3111, P.L. 111-148. Monitor the implementation of Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act, 2017, and Zika Response and Preparedness Act (P.L. 114-223). H.R. 6, House 21st Century Cures Act. H.R. 270, Flexibility in Health IT Reporting (Flex-IT) Act of 2015. H.R.775, Medicare Access to Rehabilitation Services Act of 2015. H.R. 1600, Patients' Access to Treatments Act of 2015. H.R. 1725, National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015. H.R. 1859, Ensuring Children's Access to Specialty Care Act of 2015. H.R. 2256, Veterans Information Modernization Act. H.R. 2464, Demanding Accountability for Veterans Act of 2015. H.R. 3020, House Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2015. H.R. 3309, Flex-IT 2 Act H.R. 4227, Medicare Advantage Bill of Rights. H.R. 4848, HIP Act H.R. 4909, National Defense Authorization Act for Fiscal Year 2017 H.R. 5001, Flexibility in Electronic Health Record Reporting Act. H.R. 5122, To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models. H.R. 5293, Department of Defense Appropriations, FY 2017. H.R.5721, Local Coverage Determination Clarification Act S. 480, National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015. S.539, Medicare Access to Rehabilitation Services Act of 2015. S. 2392, Medicare Advantage Bill of Rights. S. 2511, Improving Health Information Technology Act. S. 2822, Flexibility in Electronic Health Record Reporting Act S. 2943, National Defense Authorization Act for Fiscal Year 2017 S. 2978, The Protect Continuing Physician Education and Patient Care Act. S. 3000, Department of Defense Appropriations, FY 2017. S. 3040, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations, FY 2017. S.3173, EHR Regulatory Relief Act. Senate 21st Century Cures Act counterpart package, including S. 2700, S.185, S.2713, S.2745, S.2742, S.1878, S.1077, S.1101, S.2055, S.1767, S.1597, S.2512, S.2030, S.1622, S.2014, S.800, S.849, S.2503, and S.2511. Funding for NIH, CDC, DOD, related to arthritis and rheumatic disease research and education. Funding for Pediatric Subspecialty Loan Repayment Program. Draft, House Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations, FY 2017.

Client expense: $110,000 · Firm income: Not reported

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

S. 3056 - Creating and Restoring Equal Access to Equivalent Samples Act S. 1878 - Advancing Hope Act S. 2912 - Trickett Wender Right to Try Act H.R. 5122 CMMI Medicare Part B proposed demonstration Medicare Part D prescription drug program Medicare Part B payment and coding issues Senate HELP biomedical innovation/H.R. 6 - 21st Century Cures Act Value-based contracting and communications

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

Government targets: HOUSE OF REPRESENTATIVES, 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.1178, S.1466); Developing an Innovative Strategy for Antimicrobial Resistance Microorganisms Act of 2015 (DISARM) (H.R.512); Medicare Program; Part B Drug Payment Model, Proposed rule, CMS-1670-P (March 11, 2016) - Provisions related to the Medicare Part B Drug Payment Model; H.R. 5122: To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models - Suspending the Part B Drug Payment Model; Medicare Part D rebates policy issues.

Client expense: $740,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 2 - Medicare Access and CHIP Reauthorization Act of 2015 H.R. 1470/S. 810 - SGR Repeal and Medicare Provider Payment Modernization Act of 2015 Part B demonstration no specific bills, access to contraception, biosimilars guidance, immunization access, MedPAC, icd-10, Part D, CMMI H.R. 5122 - Part B demonstration

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

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

Medicare Coverage and Reimbursement Issues Part B demonstration H.R. 5122 - Part B demonstration ***, no specific bill number, reimbursement issues, Medicare Part B reimbursement, biosimilars, CMMI

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

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

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

Anti-poverty legislation HR 5122- CMS' Medicare Part B proposed regulation FY 2017 Appropriations HJ Res 1, 2, 7, 12, 28, 41 and related bills- Constitutional Balanced Budget Amendment S 3040, HR 5926- Labor, Health, Human Services, Education Appropriations HR 2028- Continuing Appropriations and Military Construction, Veterans Affairs and Related Agencies Appropriations Act, and Zika Response and Preparedness Act

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

Government targets: Equal Employment Opportunity Commission (EEOC), HOUSE OF REPRESENTATIVES, Labor, Dept of (DOL), SENATE, Social Security Administration (SSA), Substance Abuse & Mental Health Services Administration (SAMHSA), Treasury, Dept of, White House Office

HR 34- Helping Families in Mental Health Crisis Act 1115 Waivers for behavioral healthcare Anti-poverty legislation HR 5122- CMS' Medicare Part B proposed regulation S 2579- Funding for water infrastructure and other aid to address lead crisis in Flint, MI Price gouging by pharmaceutical companies Repeal of the Affordable Care Act and cuts to Medicare and Medicaid Federal income tax exclusion for employer-sponsored health care HR 2050, HR 879, S 2045, S 2075- Federal 40% tax on high-cost employer-sponsored health benefits Children's Health Insurance Program (CHIP) Parity for Puerto Rico Medicaid Funding

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

Government targets: Equal Employment Opportunity Commission (EEOC), HOUSE OF REPRESENTATIVES, Labor, Dept of (DOL), SENATE, Social Security Administration (SSA), Substance Abuse & Mental Health Services Administration (SAMHSA), Treasury, Dept of, White House Office

Issues related to orphan drugs and the value of innovative medicines. March 2016 CMS proposed rul implementing a new Part B drug payment model. H.R. 5122: To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models.

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

Government targets: HOUSE OF REPRESENTATIVES

Issues related to orphan drugs and the value of innovative medicines. March 2016 CMS proposed rule implementing a new Part B drug payment model. H.R. 5122 - To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models.

Client expense: Not reported · Firm income: $10,000

Government targets: HOUSE OF REPRESENTATIVES

Education on the importance of maintaining the competitive elements of the Part D prescription drug program and to oppose efforts to impose mandatory government rebates in that program and proposed changes to cost sharing for low income seniors. March 2016 CMS proposed rule implementing a new Part B drug payment model. H.R.5122: To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Education on the importance of maintaining the competitive elements of the Part D prescription drug program and to oppose efforts to impose mandatory government rebates in that program and changes to copay structure for low income beneficiaries. March 2016 CMS proposed rule implementing a new Part B drug payment program. H.R.5122: To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

PL 111-148 - The Patient Protection and Affordable Care Act, implementation, comparative effectiveness research, deficit reduction, PCORI budget resolution, reconciliation, deficit reduction, debt ceiling, appropriations H. Con. Res. 27 - House budget resolution S. Con. Res. 11 - Senate budget resolution H.R. 1314 - Bipartisan Budget Act of 2015 H.R. 6 - 21st Century Cures Innovation For Healthier Americans Part B demonstration H.R. 5122 - Part B demonstration H.R. 5325 - Continuing Appropriations H.R. 34 - 21st Century Cures Act no specific bills: patient engagement, alternative payment models

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

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

PL 111-148 - The Patient Protection and Affordable Care Act, implementation, ESRD, clinical laboratory payment H.R. 2 - Medicare Access and CHIP Reauthorization Act of 2015 H.R. 1470/S. 810 - SGR Repeal and Medicare Provider Payment Modernization Act of 2015 Part B demonstration H.R. 5122 - Part B demonstration H.R. 34 - 21st Century Cures Act ***, no specific bill(s), Medicare Reimbursement, Medicaid Rebate, Medicaid Coverage and Reimbursement, quality indicators, coding, MS, Infusion, oncology, CMMI S. 275/H.R. 609 - Home Infusion Site of Care Act

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

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

H.R. 696 & S. 506 (Medicare Prompt Pay Discount Exclusion), legislation to ensure more appropriate general payment amount for drugs and biologicals under Part B of the Medicare Program by excluding customary prompt-pay discounts extended to wholesalers from the manufacturer's average sales price. Average Sales Price (ASP) Generally (in the context of Deficit Reduction). H.R. 1416 legislation to exclude cancer drugs from sequestration cuts. H.R. 1934, The Cancer Care Payment Reform Act of 2015. H.R.5122 - To prohibit further action on the proposed Medicare Part B Provider Reimbursement Demonstration Project through CMS/CMMI, Medicare Access and CHIP Reauthorization Act (MACRA) implementation.

Client expense: $610,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 1465 / HR 2799: Furthering Access to Stroke Telemedicine (FAST) Act S. 2484 / HR 4442: CONNECT for Health Act; Section 303 S.3504: CHRONIC Care Act of 2016 HR 2948: Medicare Telehealth Parity Act of 2015, Section 105(a)(1) HR 5122: To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models. Preservation of the in-office ancillary exception to the Stark law; urging changes to the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA).

Client expense: Not reported · Firm income: $196,982

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Legislation and policies related to: Physician/nurse practitioner reimbursement Provisions of the Patient Protection & Affordable Care Act (P.L. 111-148) Adoption of recommendations of the Institute of Medicine report, The Future of Nursing: Leading Change, Advancing Health Medicare Shared Savings Program beneficiary assignment requirements Medicare-Medicaid hospital conditions of participation Evaluation of the Medicare Graduate Nurse Education demonstration Medicare-Medicaid Program Integrity policies Medicaid maintenance of effort requirements Medicaid eligibility expansion and state options Medicaid waiver application procedures Medicaid per capita cap policy options Medicare-Medicaid dual eligible coverage and demonstration Draft Hospital Improvement for Payment (HIP) Act HHS study on the comparability of CHIP coverage and benefits with those of marketplace health plans Medicare provisions of H.R. 1892, the Trade Adjustment Assistance Act H.R. 2 - Medicare Access and CHIP Reauthorization Act H.R. 160/S. 149 - Protect Medical Innovation Act H.R. 546/S. 298 - Advancing Care for Exceptional Kids (ACE Kids) Act H.R. 700 - Stabilize Medicaid and CHIP Coverage Act H.R. 818/S. 861 - Preventing and Reducing Improper Medicare and Medicaid Expenditures (PRIME) Act H.R. 876 - Notice of Observation Treatment and Implication for Care Eligibility (NOTICE) Act H.R. 919 - CHIP Extension and Improvement Act H.R. 1021 - Protecting Integrity of Medicare Act (PIMA) H.R. 1190/S. 141 - Protecting Seniors Access to Medicare Act H.R. 1362 - Medicaid Requiring Expenditures for Public Objectives to be Reflective of Total Spending (Medicaid REPORTS) Act H.R. 1458 - Bundling and Coordinating Post-Acute Care (BACPAC) Act H.R. 1470 - SGR Repeal and Medicare Provider Payment Modernization Act H.R. 2339 - To amend title XIX of the Social Security Act to clarify the treatment of lottery winnings and other lump sum income for purposes of income eligibility under the Medicaid program H.R. 3014 - Medical Controlled Substances Transportation Act H.R. 3134 - Defund Planned Parenthood Act of 2015 H.R. 3292 - Medicare IME Pool Act H.R. 3298 - Medicare Post-Acute Care Value-Based Purchasing Act H.R. 3716 - Ensuring Terminated Providers Are Removed From Medicaid and CHIP Act H.R. 3821/S. 2618 - Medicaid Directory of Caregivers (Medicaid DOC) Act H.R. 4588 - Incentivizing Medicaid Expansion Act of 2016 H.R. 4725 - Common Sense Savings Act of 2016 H.R. 5164 - Rural Hospital Regulatory Relief Act H.R. 5122 - To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models H.R. 5210/S. 2736 - Patient Access to Durable Medical Equipment Act H.R. 5273 - Helping Hospitals Improve Patient Care Act of 2016 H.R. 5613/S. 3129 - Continuing Access to Hospitals Act of 2016 S. 257/H.R. 1611 - Protecting Access to Rural Therapy Services Act S. 578/H.R. 1342 - Home Health Care Planning Improvement Act S. 737/H.R. 2253 - Ensuring Access to Primary Care for Women & Children Act S. 1349 - Notice of Observation Treatment and Implication for Care Eligibility (NOTICE) Act S. 1456 - Rural ACO Improvement Act S. 1461 - Extending a moratorium on enforcement of direct physician supervision of outpatient therapeutic services in critical access and small rural hospitals through 2015 S. 2425 - Patient Access and Medicare Protection Act S. 2787 - States Achieve Medicaid Expansion (SAME) Act S. 3130 - Independence at Home Act of 2016

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

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

Issues related to rare disease and orphan disease patient access in Medicaid; H.R. 5122, "To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models."

Client expense: $340,000 · Firm income: Not reported

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

Policies to enhance patient access to medicines in Medicaid; Policies to enhance patient access to medicines in Medicare; H.R. 3061 & S. 31, Medicare Prescription Drug Price Negotiation Act of 2015; H.R. 2005 & S. 1083, Medicare Drug Savings Act; H.R. 5122, To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models; Medicare payment proposals (MedPAC); Medicare Access and CHIP Reauthorization Act (MACRA);

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)

H.R. 34 21st Century Cures Act. Innovation for Healthier Americans -- Senate HELP Committee. Implementation issues related to Pharmaceutical Quality Quality, Security & Accountability Act (PL 113-54). Issues related to the 340B Drug Discount Program. Drug pricing issues. White House Cancer Moonshot & Precision Medicine initiatives. Part B Drug payment issues, CMMI Part B Payment model. Issues related to the implementation of the follow-on biologies provisions in P.L. 11-1148 "PPACA". S.2912, Trickett Wendler Right to Try Act of 2016. Pandemic Preparedness and CDC strategic national stockpile H.R.5122 - To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models.

Client expense: $1,060,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Trade Representative (USTR)

Issues relating to CMMI proposed CMMI Part B demo (81 FR 13229) 340B drug discount program. H.R. 34 21st Century Cures Act. Implementation of Medicare Pharmaceutical coverage and reimbursement. Follow-on biologies and Medicare Physician Fee schedule rule to blend ASP for biosimilars. H.R.5122, To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models.

Client expense: $1,060,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Trade Representative (USTR)

Issues related to orphan drugs and the value of innovative medicines. March 2016 CMS proposed rule implementing a new Part B drug payment model. H.R. 5122 - To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models.

Client expense: Not reported · Firm income: Not reported