Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017

Issues related to pharmaceutical manufacturer and pharmacy contracting with respect to drug pricing. Issues included in the Proposed Part D Rule and accompanying RFI and the Administrations Blueprint on drug pricing RFI . Issues related to Medicaid Provider Enrollment. Issues related to prescription drug abuse. Issues related to the Medicare Coverage Gap Discount. Regulatory design and coverage of pharmacy benefits in health reform exchanges and the commercial market (essential health benefits, e-prescribing, PBM disclosure requirements, specialty pharmacy, mail-service pharmacy, formulary transparency, and medical loss ratio). H.R.749/S.297, Lower Drug Costs through Competition Act HR.1038/S.413, Improving Transparency and Accuracy in Part D Spending Act H.R.1316, Prescription Drug Price Transparency Act S.637, Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017 S.771, Improving Access to Affordable Prescription Drug Act H.R.1939/S.1044, Ensuring Seniors Access to Local Pharmacies Act H.R. 2026, Pharmaceutical Information Exchange Act H.R.2051, FAST Generics Act H.R.2212/S.974, Creating and Restoring Equal Access To Equivalent Samples Act of 2017 H.R.2077 Restoring the Patient's Voice Act of 2017 S.2553/H.R.6144, Know the Lowest Price Act of 2018 S.2554/H.R.6143, Patient Right to Know Drug Prices Act H.R.3528/S.2460, The Every Prescription Carried Safely Act H.R.5343, Prescription Transparency Act of 2018 H.R.4841, Standardizing Electronic Prior Authorization for Safe Prescribing Act of 2018 Issues related to the affordability of prescription drugs and competitive marketplace, including: pedigree, manufacturer market and data exclusivity, REMS, accelerated generic approval, biosimilars.

Client expense: $611,446 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), SENATE

H.R. 242: Medicare Prescription Drug Price Negotiation Act of 2017 - Provisions related to Part D and drug pricing negotiation H.R. 1316: Prescription Drug Price Transparency Act - Provisions related to transparency of payment methodologies HR 1892 - Bipartisan Budget Act of 2018, provision related to Medicare Part D Doughnut Hole H.R. 3192: CHIP Mental Health Parity Act H.R. 4005: Medicaid Reentry Act H.R. 5150: Protecting Medicare from Excessive Price Increases Act of 2018 - To require drug manufacturers to pay a Medicare part B rebate for certain drugs H.R. 5675: To amend title XVIII of the Social Security Act to require prescription drug plan sponsors under the Medicare program to establish drug management programs for at-risk beneficiaries. H.R. 5797: Individuals in Medicaid Deserve Care that is Appropriate and Responsible in its Executive Act H.R. 5799: Medicaid Drug Review, Utilization, Good Governance Improvement Act H.R. 5801: Medicaid PARTNERSHIP Act H.R. 5808: Medicaid Pharmaceutical Home Act of 2018 H.R. 6505: Medicare Negotiation and Competitive Licensing Act of 2018 - Drug pricing H.R. 6642: To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs H.R. 7217: Improving Medicaid Programs and Opportunities for Eligible Beneficiaries Act or IMPROVE Act S. 41: Medicare Prescription Drug Price Negotiation Act of 2017 - Provisions related to Part D and drug pricing negotiation S. 348: Prescription Drug and Health Improvement Act of 2017 - Provisions related to Part D S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017 - Provisions related to transparency of prescription drug pricing and pharmacy benefit managers S. 870: CHRONIC Care Act of 2017 - Provisions related to Medicare and chronic care S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 - Provisions related to increases in the wholesale acquisition costs of prescription drugs S. 1688: Empowering Medicare Seniors to Negotiate Drugs Prices Act of 2017 - Part D and non-interference provisions Medicare Access and Childrens Health Insurance Program (CHIP) reauthorization policy issues Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Part D policy issues including non-interference and rebates policy issues Part B reform including MedPAC recommendations and other policy issues and local coverage decisions Drug cost and pricing policy issues Transparency policy issues Alternative payment models policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues False Claims Act policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Prescription drug abuse policy issues ANPRM; Medicare Program; International Pricing Index Model for Medicare Part B Drugs (CMS-5528-ANPRM) Proposed Rule; Medicare and Medicaid Programs; Regulation To Require Drug Pricing Transparency (CMS-4187-P) Proposed Rule; Contract Year (CY) 2020 Medicare Advantage and Part D Drug Pricing (CMS-4180-P) Request for Information: Medicare and State Health Care Programs: Fraud and Abuse; Request for Information Regarding the Anti-Kickback Statute and Beneficiary Inducements CMP; 83 Fed. Reg. 43607 (Aug. 27, 2018) Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection (RIN 0936-AA08) Final Rule; Medicare Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System changes for 2019 (CMS-1695-FC) Contract Year (CY) 2020 Medicare Advantage and Part D Drug Pricing Proposed Rule (CMS-4180-P) Medicare Part D/Medicare Part B Medicaid Protected Classes

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR)

Monitor implementation of the Patient Protection and Affordable Care Act (P.L. 111-148). Monitor federal and legislative activity related to Medicare Reimbursement. Monitor federal issues and legislation associated with health care policy. Monitor implementation of Medicare Access and CHIP Reauthorization Act of 2015 (P.L. 114-10). Monitor implementation of 21st Century Cures Act (P.L. 114-255). H.J. Res. 143, Continuing appropriations for fiscal year 2019. (P.L. 115-298) H.R. 6, SUPPORT for Patients and Communities Act. (P.L. 115-271) H.R. 849, Protecting Seniors' Access to Medicare Act of 2017. H.R. 1038, Improving Transparency and Accuracy in Medicare Part D Spending Act. H.R. 1316, Prescription Drug Price Transparency Act. H.R. 1628, American Health Care Act of 2017. H.R. 1703, Medical Product Communications Act of 2017. H.R. 1898, To improve access to, and utilization of, bone mass measurement benefits. H.R. 1920, 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.2077, Restoring the Patient's Voice Act of 2017. H.R. 2141, Conrad State 30 and Physician Access Reauthorization Act. H.R. 2267, Resident Physician Shortage Reduction Act of 2017. H.R. 2641, Promoting Life-Saving New Therapies for Neonates Act of 2017. H.R. 2999, Patients' Access to Treatments Act of 2017. H.R. 3635, Local Coverage Determination Clarification Act of 2017. H.R. 3728, EMPOWER Act of 2017. H.R. 3767, Ensuring Children's Access to Specialty Care Act of 2017. H.R. 4841, Standardizing Electronic Prior Authorization for Safe Prescribing Act of 2018. H.R. 5150, Protecting Medicare from Excessive Price Increases Act of 2018. H.R.6157, Defense and Labor, Health and Human Services Consolidated Appropriations Act, 2019. (P.L. 115-245) H.R. 6470, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2019. S. 251, Protecting Medicare from Executive Action Act of 2017. S. 260, Protecting Seniors' Access to Medicare Act of 2017. S. 637, Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017. S. 794, Local Coverage Determination Clarification Act of 2017. S. 898, Conrad State 30 and Physician Access Reauthorization Act. S. 989, Ensuring Children's Access to Specialty Care Act of 2017. S. 1301, Resident Physician Shortage Reduction Act of 2017. S. 1304, A bill 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. S. 2553, Know the Lowest Price Act of 2018 (P.L. 115-262). S. 2554, Patient Right to Know Drug Prices Act (P.L. 115-263). S. 2908, To provide for electronic prior authorization under Medicare part D for covered part D drugs, and for other purposes. S. 3158, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2019. S. 3159, Department of Defense Appropriations Act, 2019. S. 3160, To improve access to, and utilization of, bone mass measurement benefits.

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

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

Monitor implementation of the Patient Protection and Affordable Care Act (P.L. 111-148). Monitor federal and legislative activity related to Medicare Reimbursement. Monitor federal issues and legislation associated with health care policy. Monitor implementation of Medicare Access and CHIP Reauthorization Act of 2015 (P.L. 114-10). Monitor implementation of 21st Century Cures Act (P.L. 114-255). H.R. 6, SUPPORT for Patients and Communities Act. H.R. 849, Protecting Seniors' Access to Medicare Act of 2017. H.R. 1038, Improving Transparency and Accuracy in Medicare Part D Spending Act. H.R. 1316, Prescription Drug Price Transparency Act. H.R. 1628, American Health Care Act of 2017. H.R. 1703, Medical Product Communications Act of 2017. H.R. 1898, To improve access to, and utilization of, bone mass measurement benefits. H.R. 1920, 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.2077, Restoring the Patient's Voice Act of 2017. H.R. 2141, Conrad State 30 and Physician Access Reauthorization Act. H.R. 2267, Resident Physician Shortage Reduction Act of 2017. H.R. 2641, Promoting Life-Saving New Therapies for Neonates Act of 2017. H.R. 2999, Patients' Access to Treatments Act of 2017. H.R. 3635, Local Coverage Determination Clarification Act of 2017. H.R. 3728, EMPOWER Act of 2017. H.R. 3767, Ensuring Children's Access to Specialty Care Act of 2017. H.R. 4841, Standardizing Electronic Prior Authorization for Safe Prescribing Act of 2018. H.R. 5150, Protecting Medicare from Excessive Price Increases Act of 2018. H.R.6157, Defense and Labor, Health and Human Services Consolidated Appropriations Act, 2019. H.R. 6470, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2019. S. 251, Protecting Medicare from Executive Action Act of 2017. S. 260, Protecting Seniors' Access to Medicare Act of 2017. S. 637, Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017. S. 794, Local Coverage Determination Clarification Act of 2017. S. 898, Conrad State 30 and Physician Access Reauthorization Act. S. 989, Ensuring Children's Access to Specialty Care Act of 2017. S. 1301, Resident Physician Shortage Reduction Act of 2017. S. 1304, A bill 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. S. 2553, Know the Lowest Price Act of 2018 (P.L. 115-262). S. 2554, Patient Right to Know Drug Prices Act (P.L. 115-263). S. 2908, To provide for electronic prior authorization under Medicare part D for covered part D drugs, and for other purposes. S. 3158, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2019. S. 3160, To improve access to, and utilization of, bone mass measurement benefits.

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

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

Monitor implementation of the Patient Protection and Affordable Care Act (P.L. 111-148). Monitor federal and legislative activity related to Medicare Reimbursement. Monitor federal issues and legislation associated with health care policy. Monitor implementation of Medicare Access and CHIP Reauthorization Act of 2015 (P.L. 114-10). Monitor implementation of 21st Century Cures Act (P.L. 114-255). H.J. Res. 143, Continuing appropriations for fiscal year 2019. (P.L. 115-298) H.R. 6, SUPPORT for Patients and Communities Act. (P.L. 115-271) H.R. 849, Protecting Seniors' Access to Medicare Act of 2017. H.R. 1038, Improving Transparency and Accuracy in Medicare Part D Spending Act. H.R. 1316, Prescription Drug Price Transparency Act. H.R. 1628, American Health Care Act of 2017. H.R. 1703, Medical Product Communications Act of 2017. H.R. 1898, To improve access to, and utilization of, bone mass measurement benefits. H.R. 1920, 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.2077, Restoring the Patient's Voice Act of 2017. H.R. 2141, Conrad State 30 and Physician Access Reauthorization Act. H.R. 2267, Resident Physician Shortage Reduction Act of 2017. H.R. 2641, Promoting Life-Saving New Therapies for Neonates Act of 2017. H.R. 2999, Patients' Access to Treatments Act of 2017. H.R. 3635, Local Coverage Determination Clarification Act of 2017. H.R. 3728, EMPOWER Act of 2017. H.R. 3767, Ensuring Children's Access to Specialty Care Act of 2017. H.R. 4841, Standardizing Electronic Prior Authorization for Safe Prescribing Act of 2018. H.R. 5150, Protecting Medicare from Excessive Price Increases Act of 2018. H.R.6157, Defense and Labor, Health and Human Services Consolidated Appropriations Act, 2019. (P.L. 115-245) H.R. 6470, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2019. S. 251, Protecting Medicare from Executive Action Act of 2017. S. 260, Protecting Seniors' Access to Medicare Act of 2017. S. 637, Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017. S. 794, Local Coverage Determination Clarification Act of 2017. S. 898, Conrad State 30 and Physician Access Reauthorization Act. S. 989, Ensuring Children's Access to Specialty Care Act of 2017. S. 1301, Resident Physician Shortage Reduction Act of 2017. S. 1304, A bill 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. S. 2553, Know the Lowest Price Act of 2018 (P.L. 115-262). S. 2554, Patient Right to Know Drug Prices Act (P.L. 115-263). S. 2908, To provide for electronic prior authorization under Medicare part D for covered part D drugs, and for other purposes. S. 3158, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2019. S. 3159, Department of Defense Appropriations Act, 2019. S. 3160, To improve access to, and utilization of, bone mass measurement benefits.

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

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

H.R. 6642, To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs. S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017 - Provisions related to transparency of prescription drug pricing and pharmacy benefit managers S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 - Provisions related to increases in the wholesale acquisition costs of prescription drugs Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Part D policy issues including non-interference and rebates policy issues Transparency policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Final Rule; Calendar Year (CY) 2018 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System final rule with comment period (CMS-1678-FC) - Revisions to the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2018 Proposed Rule: Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program (CMS-4182-P) CMS Advanced Notice of Proposed Rulemaking on International Pricing Index Model for Medicare Part B Drugs CMS Proposed Rulemaking to Require Manufacturers to Disclose Drug Prices in Television Ads

Client expense: $1,820,000 · Firm income: Not reported

Government targets: Council of Economic Advisers (CEA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Vice President of the U.S.

Medicare Advantage Policy and Reimbursement Part D Policy and Reimbursement Medicaid and Dual Eligible Issues Pharmacy Reimbursement Issues Medicare Access and CHIP Reauthorization Act Implementation HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs Opioid Issues H.R. 6, Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act S. 3120, HEAL Act of 2018 S. 637, Creating Transparency to Have Drug Rebates Unlocked Act H.R. 3528, Every Prescription Conveyed Securely Act H.R. 6733, Know the Cost Act of 2018 S. 2553, Know the Lowest Price Act of 2018

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, Treasury, Dept of, White House Office

H.R. 242: Medicare Prescription Drug Price Negotiation Act of 2017 - Provisions related to Part D and drug pricing negotiation H.R. 1316: Prescription Drug Price Transparency Act - Provisions related to transparency of payment methodologies H.R. 3192: CHIP Mental Health Parity Act H.R. 4005: Medicaid Reentry Act H.R. 5150: Protecting Medicare from Excessive Price Increases Act of 2018 - To require drug manufacturers to pay a Medicare part B rebate for certain drugs H.R. 5590: Opioid Addiction Action Plan Act H.R. 5605: Advancing High Quality Treatment for Opioid Use Disorders in Medicare Act H.R. 5675: To amend title XVIII of the Social Security Act to require prescription drug plan sponsors under the Medicare program to establish drug management programs for at-risk beneficiaries. H.R. 5797: Individuals in Medicaid Deserve Care that is Appropriate and Responsible in its Executive Act H.R. 5799: Medicaid Drug Review, Utilization, Good Governance Improvement Act H.R. 5801: Medicaid PARTNERSHIP Act H.R. 5808: Medicaid Pharmaceutical Home Act of 2018 H.R. 5810: Medicaid Health Homes for Opioid-Use-Disorder Medicaid Enrollees Encouraged Act H.R. 6505: Medicare Negotiation and Competitive Licensing Act of 2018 - Drug pricing H.R. 6642: To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs H.R. 7217: Improving Medicaid Programs and Opportunities for Eligible Beneficiaries Act or IMPROVE Act S. 41: Medicare Prescription Drug Price Negotiation Act of 2017 - Provisions related to Part D and drug pricing negotiation S. 348: Prescription Drug and Health Improvement Act of 2017 - Provisions related to Part D S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017 - Provisions related to transparency of prescription drug pricing and pharmacy benefit managers S. 870: CHRONIC Care Act of 2017 - Provisions related to Medicare and chronic care S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 - Provisions related to increases in the wholesale acquisition costs of prescription drugs S. 1688: Empowering Medicare Seniors to Negotiate Drugs Prices Act of 2017 - Part D and non-interference provisions Medicare Access and Childrens Health Insurance Program (CHIP) reauthorization policy issues Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Part D policy issues including non-interference and rebates policy issues Part B reform including MedPAC recommendations and other policy issues and local coverage decisions Drug cost and pricing policy issues Transparency policy issues Alternative payment models policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues False Claims Act policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Changes to the Medicare Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs Prescription drug abuse policy issues ANPRM; Medicare Program; International Pricing Index Model for Medicare Part B Drugs (CMS-5528-ANPRM) Proposed Rule; Medicare and Medicaid Programs; Regulation To Require Drug Pricing Transparency (CMS-4187-P) Proposed Rule; Contract Year (CY) 2020 Medicare Advantage and Part D Drug Pricing (CMS-4180-P) Request for Information: Medicare and State Health Care Programs: Fraud and Abuse; Request for Information Regarding the Anti-Kickback Statute and Beneficiary Inducements CMP; 83 Fed. Reg. 43607 (Aug. 27, 2018) Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection (RIN 0936-AA08)

Client expense: $6,030,000 · 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), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)

340B Drug Discount Program ---Program Implementation & Oversight ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 ---H.R. 4710: 340B Pause Act ---H.R. 5598: 340B Optimization Act Access to Medicines/World Health Organization Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---H.R. 6378/S.2852: Pandemic and All-Hazards Preparedness and Innovation Act (PAHPAIA) ---H.R. 7328: Pandemic and All-Hazards Preparedness and Innovation Act of 2018 ---National Biodefense Strategy ---Gene Editing Biosimilars ---Access to Samples for Testing ---Coding ---Naming ---Interchangeability and Pharmacy Substitution ---S. 974/H.R. 2212: CREATES Act of 2017 Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Proposed Rule on Changes to Drug Labeling ---Patient-Focused Drug Development ---Prescription Drug User Fee Act (PDUFA) VI Implementation ---FDA Management & Financial Accountability ---FDA Hiring Flexibility ---Priority Review Voucher Program ---Regulatory Reform & Modernization ---Use of Real World Evidence Drug Importation ---S.469: Affordable and Safe Prescription Drug Importation Act ---S.771: Improving Access to Affordable Prescription Drugs ---General Drug Manufacturing, Quality & Distribution ---Pharmacy Compounding & Oversight ---Drug Shortages ---Supply Chain Integrity and Traceability ---Counterfeiting Drug Pricing ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S. 1369 / H.R. 2974: Stop Price Gouging Act ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---S. 771: Improving Access to Affordable Prescription Drugs ---H.R. 6505: Medicare Negotiation and Competitive Licensing Act of 2018 Funding for Antimicrobial Resistance Programs ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 ---FY 2020 Labor, HHS, Education Appropriations (Discussion Draft House/Senate) Funding for National Institutes of Health ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 Generic Drug Entry ---Access to Samples for Testing ---Generic Drug Application Review Reforms ---S. 974/H.R. 2212: CREATES Act of 2017 ---H.R. 749: Lower Drug Costs Through Competition Act ---Incentives for Generic Drug Entry ---H.R. 297: Increasing Competition in Pharmaceuticals Act Medicaid ---Drug Benefit Design ---Pricing and Rebates ---Average Manufacturer Price Calculations The United States-Mexico-Canada Agreement ---Pricing and Reimbursement Provisions ---IP Provisions ---Regulatory Harmonization US-UK Trade Agreement ---IP Provisions ---Pricing and Reimbursement Provisions ---Regulatory Harmonization US-EU Trade Agreement ---IP Provisions ---Pricing and Reimbursement Provisions ---Regulatory Harmonization US-Japan Trade Agreement ---IP Provisions ---Pricing and Reimbursement Provisions ---Regulatory Harmonization Opioid Crisis ---NIH Research ---FDA Reforms ---Coverage and Reimbursement ---Transparency ---H.R. 5590: Opioid Addiction Action Plan Act ---H.R. 5002: Advancing Cutting Edge Research Act ---H.R. 5473: Better Pain Management Through Better Data Act ---H.R. 5806: 21st Century Tools for Pain Addiction Treatment ---H.R. 6: SUPPORT for Patients and Communities Act ---S.2665: Providing Clarity in Development of Pain Treatment ---S.2669: Advancing Innovation in Alternative Pain and Addiction Therapies Act ---S.2680: Opioid Crisis Response Act ---S.2769: HEAL Act Orphan Drug Issues ---Tax Credit Reimbursement for Innovative Products ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Third Party Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---S. 771: Improving Access to Affordable Prescription Drugs ---H.R. 6505: Medicare Negotiation and Competitive Licensing Act of 2018 Trade and Foreign Drug Price Controls Vaccines and Infectious Diseases ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Adult Immunization Education ---Vaccine Quality Measure Diagnostic and Personalized Medicine Regulation and Oversight Precision Medicine Initiative

Client expense: $2,500,000 · 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 Institutes of Health (NIH), Natl Security Council (NSC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

PL 114-255 - 21st Century Cures, implementation S. 771 - Improving Access to Affordable Prescription Drugs Act S. 637 - Creating Transparency to Have Drug Rebates Unlocked Act of 2017 Stopping the Pharmaceutical Industry From Keeping Drugs Expensive Act of 2017 S. 469 - Affordable and Safe Prescription Drug Importation act H.R. 749 - Lower Drug Costs Through Competition Act H.R. 878/S. 204 - Right to Try Act H.R. 2430 - FDA Reauthorization Act of 2017 S. 260/H.R. 849 - Protecting Seniors' Access to Medicare Act of 2017 S. 2852 - Pandemic and All Hazards Preparedness Act H.R. 6 - SUPPORT for Patients and Communities Act no specific bil1s, innovation, non-interference, 340B, Hepatitis C, HPV, Shingles, anti-microbial resistance, transparency, Pandemic All Hazards Preparedness Act reauthorization

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

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

Health reform proposals that impact Medicare Part D such as formulary requirements, PBM disclosure provisions, closing the Part D coverage gap and direct negotiation of prescription drug prices. Researching and responding to the Administration's America's Patients First drug pricing blueprint. Medicare Part B reforms. S 637; HR 1920; HR 1939. Medical utilization management and Medicare Advantage program policy and operations; S 2553 and S 2554 - Prohibition on pharmacy "gag clauses."

Client expense: $840,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Internal Revenue Service (IRS), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Office of Personnel Management (OPM), SENATE, White House Office

General education about the pharmacy benefit manager/pharmacy industry, including S.637, The Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act. Issues related to Risk Evaluation and Mitigation Strategies (REMS) program, including S.974 and H. R. 2212, The CREATES Act. Proactive measures to curb opioid abuse, including H. R. 3528, Every Prescription Conveyed Securely Act, and H. R. 4841, Standardizing Electronic Prior Authorization for Safe Prescribing Act of 2018, as well as H.R. 6, the SUPPORT for Patients and Communities Act.

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

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

General education about the pharmacy benefit manager/pharmacy industry, including S.637, The Creating Transparency to Have Drug Rebates Unlocked (C-THRU)Act. Issues related to access and affordability of health care for veterans. Issues related to the proposed CVS-Aetna merger. Legislative efforts to address the opioid epidemic, including H. R. 3528, Every Prescription Conveyed Securely Act, and H. R. 4841, Standardizing Electronic Prior Authorization for Safe Prescribing Act of 2018, as well as H.R. 6, the SUPPORT for Patients and Communities Act.

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

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

Lobby members of Congress to conduct oversight of implementation of Public Law 113-54, the Drug Quality and Security Act and to protect and preserve the use of compounded pharmaceuticals in the physician office prior to receipt of a patient prescription. Lobby members of Congress to direct the FDA to issue rulemaking pertaining to physicians access to compounded medications for use in the physician office setting. Lobby members of Congress regarding issues related to telemedicine. Advocate for increased transparency regarding drug pricing. Lobby members of the House to join the Congressional Skin Cancer Caucus. Lobby members of Congress to support H. Res. 282 to encourage proper sun safety practices for youth under care of schools and camps. Advocate for adequate and accurate network coverage for dermatologic care within health insurance exchange networks. Support H.R. 2871, Preserving Patient Access to Compounded Medications Act. Support H.R. 2077, Restoring Patients Voice Act. Support H.R. 1316, Prescription Drug Price Transparency Act. Support H.R. 2051, Fair Access for Safe and Timely Generics Act. Support H.R. 2212/S. 974, Creating and Restoring Equal Access to Equivalent Samples Act. Support H.R. 2999, Patients Access to Treatments Act. Support H.R. 3928, the Truth in Healthcare Marketing Act of 2017. Support S. 637, C-THRU Act. Support S. 989, Ensuring Childrens Access to Specialty Care Act. Support H.R. 5958, Phair Pricing Act. Support H.R. 6689/S. 3368, Ensuring Lasting Smiles Act. Advocate for relief for from prior authorization requirements under Medicare Advantage and Medicare Part D plans. Support H.R. 4841/H.R. 5773/Section 6062 of H.R. 6 (SUPPORT for Patients & Communities Act), Standardizing Electronic Prior Authorization for Safe Prescribing Act and S. 2908, Electronic Prior Authorization in Medicare Part D Act. Support sunscreen related provisions in S. 2315, OTC Drug Safety, Innovation & Reform Act/H.R. 5333, OTC Monograph Safety, Innovation, & Reform Act. Support pediatric subspecialty loan repayment in any reauthorization of the Title VII programs. Advocate for access to dermatological procedures for veterans through the Veterans Choice Program. Advocate for the continued funding of Community Health Centers. Advocate against including physician advocacy and membership organization in the Physician Payment Sunshine Act requirements as originally included in S. 3000; advocated against inclusion in S. Amendment 4013 to H.R. 6.

Client expense: $360,000 · Firm income: Not reported

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

Lobby members of Congress to conduct oversight of implementation of Public Law 113-54, the Drug Quality and Security Act and to protect and preserve the use of compounded pharmaceuticals in the physician office prior to receipt of a patient prescription. Lobby members of Congress to direct the FDA to issue rulemaking pertaining to physicians access to compounded medications for use in the physician office setting. Support H.R. 2871, Preserving Patient Access to Compounded Medications Act. Support H.R. 1316, Prescription Drug Price Transparency Act Support S. 637, C-THRU Act. Support H.R. 5958, Phair Pricing Act Support sunscreen related provisions in S. 2315, OTC Drug Safety, Innovation & Reform Act/H.R. 5333, OTC Monograph Safety, Innovation, & Reform Act; provisions also included in H.R. 7328, Pandemic and All-Hazards Preparedness and Advancing Innovation Act.

Client expense: $360,000 · Firm income: Not reported

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

H.R. 1316, Prescription Drug Price Transparency Act; H.R. 1038, Improving Transparency and Accuracy in Medicare Part D Spending Act; S. 413, Improving Transparency and Accuracy in Medicare Part D Spending Act; H.R. 592, Pharmacy and Medically Underserved Areas Enhancement Act; S. 109, Pharmacy and Medically Underserved Areas Enhancement Act; H.R.1939 - To amend title XVIII of the Social Security Act to ensure equal access of Medicare beneficiaries to community pharmacies in underserved areas as network pharmacies under Medicare prescription drug coverage, and for other purposes; S.637 Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017; HR 394/ S 85, Restoring Access to Medication Act; HR 3921/S 1827, KIDS Act of 2017; HR 3271, Protecting Access to Diabetes Supplies Act of 2017; S. 870, Creating High-Quality Results and Outcomes Necessary to Improve Chronic (CHRONIC) Care Act of 2017; Centers for Medicare and Medicaid Services (CMS) Proposed Rule for the 2019 Medicare Part D Plan Year, pharmacy provisions; S.2553 / H.R. 6144, Know the Lowest Price Act of 2018; S.2554 / H.R. 6143, Patient Right to Know Drug Prices Act; H.R. 5343, Prescription Transparency Act of 2018; H.R. 5958, Phair Pricing Act of 2018; CMS Call Letter for 2019 Medicare Part D and Medicare Advantage Plans; H.R. 6733, Know the Cost Act of 2018; H.R. 6641, COST Act; H.R. 7339, Medicare for America Act of 2018; Proposed Rule, "Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses, CMS-4180-P"

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

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), Office of Personnel Management (OPM), SENATE, Small Business Administration (SBA), Substance Abuse & Mental Health Services Administration (SAMHSA), 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). Monitor implementation of 21st Century Cures Act (P.L. 114-255). H.J. Res. 143, Continuing appropriations for fiscal year 2019. (P.L. 115-298) H.R. 6, SUPPORT for Patients and Communities Act. (P.L. 115-271) H.R. 849, Protecting Seniors' Access to Medicare Act of 2017. H.R. 1038, Improving Transparency and Accuracy in Medicare Part D Spending Act. H.R. 1316, Prescription Drug Price Transparency Act. H.R. 1628, American Health Care Act of 2017. H.R. 1703, Medical Product Communications Act of 2017. H.R. 1898, To improve access to, and utilization of, bone mass measurement benefits. H.R. 1920, 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.2077, Restoring the Patient's Voice Act of 2017. H.R. 2141, Conrad State 30 and Physician Access Reauthorization Act. H.R. 2267, Resident Physician Shortage Reduction Act of 2017. H.R. 2641, Promoting Life-Saving New Therapies for Neonates Act of 2017. H.R. 2999, Patients' Access to Treatments Act of 2017. H.R. 3635, Local Coverage Determination Clarification Act of 2017. H.R. 3728, EMPOWER Act of 2017. H.R. 3767, Ensuring Children's Access to Specialty Care Act of 2017. H.R. 4841, Standardizing Electronic Prior Authorization for Safe Prescribing Act of 2018. H.R. 5150, Protecting Medicare from Excessive Price Increases Act of 2018. H.R.6157, Defense and Labor, Health and Human Services Consolidated Appropriations Act, 2019. (P.L. 115-245) H.R. 6470, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2019. S. 251, Protecting Medicare from Executive Action Act of 2017. S. 260, Protecting Seniors' Access to Medicare Act of 2017. S. 637, Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017. S. 794, Local Coverage Determination Clarification Act of 2017. S. 898, Conrad State 30 and Physician Access Reauthorization Act. S. 989, Ensuring Children's Access to Specialty Care Act of 2017. S. 1301, Resident Physician Shortage Reduction Act of 2017. S. 1304, A bill 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. S. 2553, Know the Lowest Price Act of 2018 (P.L. 115-262). S. 2554, Patient Right to Know Drug Prices Act (P.L. 115-263). S. 2908, To provide for electronic prior authorization under Medicare part D for covered part D drugs, and for other purposes. S. 3158, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2019. S. 3159, Department of Defense Appropriations Act, 2019. S. 3160, To improve access to, and utilization of, bone mass measurement benefits.

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

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

Monitor implementation of the Patient Protection and Affordable Care Act (P.L. 111-148). Monitor federal and legislative activity related to Medicare Reimbursement. Monitor federal issues and legislation associated with health care policy. Monitor implementation of Medicare Access and CHIP Reauthorization Act of 2015 (P.L. 114-10). Monitor implementation of 21st Century Cures Act (P.L. 114-255). H.J. Res. 143, Continuing appropriations for fiscal year 2019. (P.L. 115-298) H.R. 6, SUPPORT for Patients and Communities Act. (P.L. 115-271) H.R. 849, Protecting Seniors' Access to Medicare Act of 2017. H.R. 1038, Improving Transparency and Accuracy in Medicare Part D Spending Act. H.R. 1316, Prescription Drug Price Transparency Act. H.R. 1628, American Health Care Act of 2017. H.R. 1703, Medical Product Communications Act of 2017. H.R. 1898, To improve access to, and utilization of, bone mass measurement benefits. H.R. 1920, 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.2077, Restoring the Patient's Voice Act of 2017. H.R. 2141, Conrad State 30 and Physician Access Reauthorization Act. H.R. 2267, Resident Physician Shortage Reduction Act of 2017. H.R. 2641, Promoting Life-Saving New Therapies for Neonates Act of 2017. H.R. 2999, Patients' Access to Treatments Act of 2017. H.R. 3635, Local Coverage Determination Clarification Act of 2017. H.R. 3728, EMPOWER Act of 2017. H.R. 3767, Ensuring Children's Access to Specialty Care Act of 2017. H.R. 4841, Standardizing Electronic Prior Authorization for Safe Prescribing Act of 2018. H.R. 5150, Protecting Medicare from Excessive Price Increases Act of 2018. H.R.6157, Defense and Labor, Health and Human Services Consolidated Appropriations Act, 2019. (P.L. 115-245) H.R. 6470, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2019. S. 251, Protecting Medicare from Executive Action Act of 2017. S. 260, Protecting Seniors' Access to Medicare Act of 2017. S. 637, Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017. S. 794, Local Coverage Determination Clarification Act of 2017. S. 898, Conrad State 30 and Physician Access Reauthorization Act. S. 989, Ensuring Children's Access to Specialty Care Act of 2017. S. 1301, Resident Physician Shortage Reduction Act of 2017. S. 1304, A bill 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. S. 2553, Know the Lowest Price Act of 2018 (P.L. 115-262). S. 2554, Patient Right to Know Drug Prices Act (P.L. 115-263). S. 2908, To provide for electronic prior authorization under Medicare part D for covered part D drugs, and for other purposes. S. 3158, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2019. S. 3159, Department of Defense Appropriations Act, 2019. S. 3160, To improve access to, and utilization of, bone mass measurement benefits.

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

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

S. 637 - Creating Transparency to have Drug Rebates Unlocked (C-THRU). Medicare Advantage Policy and Reimbursement. Medicare Part D issues. Medicaid and Dual Eligible issues. Pharmacy Reimbursement issues. Medicare Access and CHIP Reauthorization Act Implementation. H.R. 6 - SUPPORT for Patients and Communities Act. S. 3120 - HEAL Act of 2018. Request for Information 0991-ZA49, HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs.

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

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

PL 114-255 - 21st Century Cures, implementation S. 771 - Improving Access to Affordable Prescription Drugs Act S. 637 - Creating Transparency to Have Drug Rebates Unlocked Act of 2017 Stopping the Pharmaceutical Industry From Keeping Drugs Expensive Act of 2017 S. 469 - Affordable and Safe Prescription Drug Importation act H.R. 749 - Lower Drug Costs Through Competition Act S. 204 - Right to Try Act of 2017 S. 456 - RACE for Children Act H.R. 2430 - FDA Reauthorization Act of 2017 ***, no specific bill, Raising Awareness of Cystic Fibrosis ***, no specific bill, appropriations for the Department of Health and Human Services, PDUFA, Sunshine, Orphan drugs, 340B, Innovation, EXPERT, Non-interference, drug development policies

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. 1776/S. 771 - Improving Access to Affordable Prescription Drugs Act S. 637 - Creating Transparency to Have Drug Rebates Unlocked Act of 2017 H.R. 1245/S. 469 - Affordable and Safe Prescription Drug Importation Act Stopping the Pharmaceutical Industry From Keeping Drugs Expensive Act of 2017 H.R. 749 - Lower Drug Costs Through Competition Act H.R. 1316 - Prescription Drug Price Transparency Act H.R. 2430 - FDA Reauthorization Act of 2017 H.R. 878/S. 204 - Right to Try Act S. 2852 - Pandemic and All Hazards Preparedness Act H.R. 6 - SUPPORT for Patients and Communities Act no specific bill, non-interference, 340b, FDASIA implementation, emergency preparedness, counter measures

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

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

PL 114-255 - 21st Century Cures, implementation S. 204 - Right to Try Act of 2017 S. 456 - RACE for Children Act S. 771 - Improving Access to Affordable Prescription Drugs Act S. 637 - Creating Transparency to Have Drug Rebates Unlocked Act of 2017 Stopping the Pharmaceutical Industry From Keeping Drugs Expensive Act of 2017 S. 469 - Affordable and Safe Prescription Drug Importation act H.R. 749 - Lower Drug Costs Through Competition Act H.R. 2430 - FDA Reauthorization Act of 2017 no specific bills: Innovation, Duchenne Muscular Dystrophy, platform technologies, non-interference

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

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

PL 114-255 - 21st Century Cures, implementation S. 771 - Improving Access to Affordable Prescription Drugs Act S. 637 - Creating Transparency to Have Drug Rebates Unlocked Act of 2017 Stopping the Pharmaceutical Industry From Keeping Drugs Expensive Act of 2017 S. 469 - Affordable and Safe Prescription Drug Importation Act H.R. 749 - Lower Drug Costs Through Competition Act H.R. 2430 - FDA Reauthorization Act of 2017 S. 2852 - Pandemic and All Hazards Preparedness Act no specific bills - innovation, non-interference, biosimilars, prescription drug access and affordability

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office

PL 114-255 - 21st Century Cures, implementation S. 771 - Improving Access to Affordable Prescription Drugs Act S. 637 - Creating Transparency to Have Drug Rebates Unlocked Act of 2017 Stopping the Pharmaceutical Industry From Keeping Drugs Expensive Act of 2017 S. 456 - RACE for Children Act S. 469 - Affordable and Safe Prescription Drug Importation act H.R. 749 - Lower Drug Costs Through Competition Act H.R. 878/S. 204 - Right to Try Act of 2017 H.R. 1480/S. 64/S. 92 - Safe and Affordable Drugs from Canada Act H.R. 2430 - FDA Reauthorization Act of 2017 H.R. 6 - SUPPORT for Patients and Communities Act S. 3120 - HEAL Substance Use Disorders Act S. 2680 - Opioid Crisis Response Act no specific bills, 340B, Innovation, Transparency, Precision Medicine, NIH, Importation, Non-Interference, Vaccines, Biosimilars, Compounding

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

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

prescription drug abuse and deterrence, non-interference PL 114-255 - 21st Century Cures, implementation Multi-modal analgesics S. 771 - Improving Access to Affordable Prescription Drugs Act S. 637 - Creating Transparency to Have Drug Rebates Unlocked Act of 2017 Stopping the Pharmaceutical Industry From Keeping Drugs Expensive Act of 2017 S. 469 - Affordable and Safe Prescription Drug Importation act H.R. 749 - Lower Drug Costs Through Competition Act H.R. 2430 - FDA Reauthorization Act of 2017 H.R. 3921 - Healthy Kids Act S. 1827 - Kids Act of 2017 S. 260/H.R. 849 - Protecting Seniors' Access to Medicare Act of 2017 H.R. 6 - SUPPORT for Patients and Communities Act S. 3120 - HEAL Substance Use Disorders Act S. 2680 - Opioid Crisis Response Act S. 2852 - Pandemic and All Hazards Preparedness Act S. 3282 - DEA Clearinghouse Act of 2018

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

PL 114-255 - 21st Century Cures, implementation H.R. 2430 - FDA Reauthorization Act of 2017 S. 771 - Improving Access to Affordable Prescription Drugs Act S. 637 - Creating Transparency to Have Drug Rebates Unlocked Act of 2017 Stopping the Pharmaceutical Industry From Keeping Drugs Expensive Act of 2017 S. 469 - Affordable and Safe Prescription Drug Importation act H.R. 749 - Lower Drug Cost Through Competition Act H.R. 1231/S. 456 - RACE for Children Act H.R. 6 - SUPPORT for Patients and Communities Act no specific bills; user fee reauthorization, non-interference, dormant therapies, drug shortages, prescription drug access and affordability

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

PL 114-255 - 21st Century Cures, implementation S. 456 - RACE for Children Act S. 771 - Improving Access to Affordable Prescription Drugs Act S. 637 - Creating Transparency to Have Drug Rebates Unlocked Act of 2017 Stopping the Pharmaceutical Industry From Keeping Drugs Expensive Act of 2017 S. 469 - Affordable and Safe Prescription Drug Importation act H.R. 749 - Lower Drug Costs Through Competition Act H.R. 878/S. 204 - Right to Try Act of 2017 H.R. 1480/S. 64/S. 92 - Safe and Affordable Drugs from Canada Act of 2017 H.R. 2430 - FDA Reauthorization Act of 2017 H.R. 6 - SUPPORT for Patients and Communities Act S. 3120 - HEAL Substance Use Disorders Act S. 2680 - Opioid Crisis Response Act S. 2852 - Pandemic and All Hazards Preparedness Act ***, no specific bill(s), health care reform, Biosimilars, PDUFA and related FDA policies, Innovation, 340B, comparative effectiveness research, user fee reauthorization, non-interference, IPAB

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE

Issues related to pharmaceutical drug pricing and transparency. S. 1348 - SPIKE Act of 2017. S. 637 - C-THRU Act of 2017. Issues related to the illegal importation of prescription drugs.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

PL114-255 - 21st Century Cures, implementation S. 771 - Improving Access to Affordable Prescription Drugs Act S. 637 - Creating Transparency to Have Drug Rebates Unlocked Act of 2017 Stopping the Pharmaceutical Industry From Keeping Drugs Expensive Act of 2017 H.R. 1245/S. 469 - Affordable and Safe Prescription Drug Importation Act H.R. 749 - Lower Drug Costs Through Competition Act S. 64/S. 92/H.R. 1480 - Safe and Affordable Drugs from Canada Act H.R. 1245 - Affordable and Safe Prescription Drug Importation Act H.R. 1776 - Improving Access to Affordable Prescription Drugs Act no specific bill - FDA implementation issues, 340B, biosimilars, non-interference, patient assistance, importation, Puerto Rico

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

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

H.R. 849, S. 260, S. 251 Protecting Seniors Access to Medicare Act, lobbied regarding all biopharmaceutical related provisions. S.771, Improving Access To Affordable Prescription Drugs Act, lobbied regarding all biopharmaceutical related provisions. S.348, Prescription Drug and Health Improvement Act of 2017, lobbied regarding all biopharmaceutical related provisions. S.637, Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017, lobbied regarding all biopharmaceutical related provisions. No bill, American Patients First Prescription Drug Blueprint, regarding all biopharmaceutical related provisions. H.R. 6505, Medicare Negotiation and Competitive Licensing Act of 2018, regarding all biopharmaceutical related provisions. H.R. 6642, to amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs, regarding all biopharmaceutical related provisions. S. 2553, H.R. 6144, Know the Lowest Price Act of 2018, regarding all biopharmaceutical related provisions.

Client expense: $940,000 · Firm income: Not reported

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

Bipartisan Health Care Stabilization Act, support bipartisan efforts led by Senators Alexander and Murray to stabilize and improve the individual health insurance market while protecting people with chronic conditions. -H.R. 2439/S. 1131, FAIR Drug Pricing Act, support passage. - H.R. 2212/ S. 974, Creating and Restoring Equal Access To Equivalent Samples Act of 2017 (CREATES Act), support passage. -H.R. 2077, Restoring Patients Voice Act, support passage. -S. 637, Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act, support passage. -H.R. 4841/S. 2908, Standardizing Electronic Prior Authorization for Safe Prescribing Act, support passage. - H.R. 2051, Fair Access for Safe and Timely Generics Act of 2017 (FAST Generics Act), support passage. -H.R. 750, support passage of the Ensuring Access to Quality Complex Rehabilitation Technology Act. -H.R. 1361/S. 486/H.R. 3730, support passage to protect access to complex rehabilitative technology accessories. -H.R. 2535/S. 1188, Lifespan Respite Care Reauthorization Act, support reauthorization of the Lifespan Respite Care Program. -HR 2575/S. 1909, Beneficiary Enrollment Notification and Eligibility Simplification (BENES) Act

Client expense: $59,856 · Firm income: Not reported

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

S 3702/HR 7223 - Tax legislation, provisions regarding generic drugs S 3738/HR 7251 - Patent legislation regarding inter partes review HR 302 - FAA Re-authorization (provisions related to air ambulance services HR 7217 - IMPROVE Act Blueprint on Drug Pricing State Reinsurance Program H.R. 6 - The Support for Patients and Communities Act S 1835 - Lower Premiums through Reinsurance Act of 2017. Collins (R-ME) HR 3545 - Overdose Prevention and Patient Safety Act. Murphy (R-PA) S 1850 - Protecting Jessica Grubbs Legacy Act. Manchin (D-WV) HR 4200 & S 2052 - To provide for temporary funding for health insurance cost-sharing reduction payments and provide targeted tax relief, and for other purposes. HR 2212 & S 974 - Creating and Restoring Equal Access To Equivalent Samples Act of 2017: A bill to promote competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products. Marino (R-PA) & Leahy (D-VT) S 1354 - Individual Health Insurance Marketplace Improvement Act: A bill to establish an individual market reinsurance fund to provide funding for state individual market stabilization reinsurance programs. Carper (D-DE) S 1859 - Healthcare Tax Relief Act: A bill to extend the moratorium on the annual fee on health insurance providers. Gardner (R-CO) H.R. 1215 - Protecting Access to Care Act of 2017: To improve patient access to health care services and provide improved medical care by reducing the excessive burden the liability system places on the health care delivery system. King (R-IA) H.R.1101 - Small Business Health Fairness Act of 2017: To amend title I of the Employee Retirement Income Security Act of 1974 to improve access and choice for entrepreneurs with small businesses with respect to medical care for their employees. Johnson (R-TX). S. 974 and H.R. 2212 - Creates Act of 2017: To promote competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products. Leahy (D-VT) & Marino (R-PA). HR 173 and S 40 - Middle Class Health Benefits Tax Repeal Act of 2017: To amend the Internal Revenue Code of 1986 to repeal the excise tax on high cost employer-sponsored health coverage. Kelly (R-PA) & Heller (R-NV). HR 708 - State Age Rating Flexibility Act of 2017: To amend title XXVII of the Public Health Service Act to change the permissible age variation in health insurance premium rates. Buschon (R-IN). HR 710 -Health Coverage State Flexibility Act of 2017: To amend the Patient Protection and Affordable Care Act to better align the grace period required for non-payment of premiums before discontinuing coverage under qualified health plans with such grace periods provided for under State law. Flores (R-TX). HR 749 - Lower Drug Costs through Competition Act: To increase competition in the pharmaceutical industry. Schrader (D-OR) H.R.1121 - Pre-existing Conditions Protection Act of 2017: To amend the Public Health Service Act to prohibit application of pre-existing condition exclusions and to guarantee availability of health insurance coverage in the individual and group market, contingent on the enactment of legislation repealing the Patient Protection and Affordable Care Act, and for other purposes. Walden (R-OR). HR 1175 and S 403 - Health Savings Act of 2017: To amend the Internal Revenue Code of 1986 to improve access to health care through expanded health savings accounts, and for other purposes. Paulsen (R-MN) & Hatch (R-UT). HR 1304 - Self-Insurance Protection Act: To amend the Employee Retirement Income Security Act of 1974, the Public Health Service Act, and the Internal Revenue Code of 1986 to exclude from the definition of health insurance coverage certain medical stop-loss insurance obtained by certain plan sponsors of group health plans. Roe (R-TN) HR 1776 & S 771 Improving Access To Affordable Prescription Drugs Act: To improve access to affordable prescription drugs. Schakowsky (D-IL) & Franken (D-MN) HR 2051 - To amend the Federal Food, Drug, and Cosmetic Act to ensure that eligible product developers have competitive access to approved drugs and licensed biological products, so as to enable eligible product developers to develop and test new products, and for other purposes. McKinley (R-WV) S 191 - Patient Freedom Act of 2017: To improve patient choice by allowing States to adopt market based alternatives to the Affordable Care Act that increase access to affordable health insurance and reduce costs while ensuring important consumer protections and improving patient care. Cassidy (R-LA) S 637 - Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017: To amend titles XI and XVIII of the Social Security Act to provide greater transparency of discounts provided by drug manufacturers. Wyden (D-OR) HR - 6082 Overdose Prevention and Patient Safety Act S 2554 Patient Right to Know Drug Prices Act

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

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

Educate Members on pharmacy contracting with pharmacy benefit managers Monitoring legislation: H.R. 1316 Prescription Drug Price Transparency Act S. 637 Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act S. 2554 Patient Right to Know Drug Prices Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Implementation of the Patient and Affordable Care Act (P.L. 11-148); Legislation Amending or Repealing P.L. 111-148; S. 637, C-Thru Act; HR 1939, Ensuring Seniors Access to Local Pharmacies Act; Electronic Pricing; Chronic Care; PBM Disclosure; Formulary Requirements; Generic Drug Co-Payments; Essential Health Benefits; and Preferred Pharmacy Networks.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 6 - Support for Patients and Communities Act - Support for policies that help to fight the opioid epidemic with a focus on safe prescriptions. S. 3120 - Helping to End Addiction and Lessen Substance Use Disorders Act - Support for policies that help to fight the opioid epidemic with a focus on safe prescriptions. H.R. 3528/S. 2460 - Every Prescription Conveyed Securely Act - Support for electronic prescribing of opioids to enhance patient safety. S. 2553 - Know the Lowest Price Act of 2018 - Support for the elimination of " gag clauses" in the Medicare Part D program. S. 2554 - Patient Right to Know Act Drug Prices Act of 2018 - Support for for the elimination of "gag clauses" in the private insurance market. CMS Regulations related to the Medicare Part D program and Prescription Drug Plans(PDPs). FDA work on addressing drug shortages in the U.S. S. 637 - Creating Transparency to Have Prescription Drug Rebates Unlocked - Issues related to the alleged relationship between rebates and drug prices. S. 771 - A Bill to Improve Access to Affordable Prescription Drugs - Issues related to bringing drug prices down including strengthening policies in the Part D coverage gap, couponing and advancing biosimilars. Education activities for Members and staff related to Direct and Indirect Renumeration(DIR)policies. Education activities related to the cross referencing of certain data related to Medicare Parts A, B and D. Trump Administration's Blueprint for lowering the price of prescription medications in the United States and the role that PBMs can play in doing so.

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

H.R. 6 - Support for Patients and Communities Act - Support for policies that help to fight the opioid epidemic with a focus on safe prescriptions. S. 3120 - Helping to End Addiction and Lessen Substance Use Disorders Act - Support for policies that help to fight the opioid epidemic with a focus on safe prescriptions. H.R. 3528/S. 2460 - Every Prescription Conveyed Securely Act - Support for electronic prescribing of opioids to enhance patient safety. S. 2553 - Know the Lowest Price Act of 2018 - Support for the elimination of " gag clauses" in the Medicare Part D program. S. 2554 - Patient Right to Know Act Drug Prices Act of 2018 - Support for for the elimination of "gag clauses" in the private insurance market. CMS Regulations related to the Medicare Part D program and Prescription Drug Plans(PDPs). FDA work on drug shortages and solutions. S. 637 - Creating Transparency to Have Prescription Drug Rebates Unlocked - Issues related to the alleged relationship between rebates and drug prices. S. 771 - A Bill to Improve Access to Affordable Prescription Drugs - Issues related to bringing drug prices down including strengthening policies in the Part D coverage gap, couponing and advancing biosimilars. Education activities for Members and staff related to Direct and Indirect Renumeration(DIR)policies. Education activities related to the cross referencing of certain data related to Medicare Parts A, B and D. Trump Administration's Blueprint for lowering the price of prescription medications in the United States and the role that PBMs can play in doing so.

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

H.R. 6 - Support for Patients and Communities Act - Support for policies that help to fight the opioid epidemic with a focus on safe prescriptions in the Medicare program. S. 3120 - Helping to End Addiction and Lessen Substance Use Disorders Act - Support for policies that help to fight the opioid epidemic with a focus on safe prescriptions in the Medicare program. H.R. 3528/S. 2460 - Every Prescription Conveyed Securely Act - Support for electronic prescribing of opioids to enhance patient safety. S. 2553 - Know the Lowest Price Act of 2018 - Support for the elimination of " gag clauses" in the Medicare Part D program. CMS Regulations related to the Medicare Part D program and Prescription Drug Plans(PDPs). S. 637 - Creating Transparency to Have Prescription Drug Rebates Unlocked - Issues related to the alleged relationship between rebates and drug prices. S. 771 - A Bill to Improve Access to Affordable Prescription Drugs - Issues related to bringing drug prices down including strengthening policies in the Part D coverage gap, couponing and advancing biosimilars. Education activities for Members and staff related to Direct and Indirect Renumeration(DIR)policies. Education activities related to the cross referencing of certain data related to Medicare Parts A, B and D. Trump Administration's Blueprint for lowering the price of prescription medications in the United States and the role that PBMs can play in doing so.

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

S. 2553 - Know the Lowest Price Act of 2018- Support of the elimination of "gag clauses" in Medicare Part D. H.R. 6 - Support for Patients and Communities Act - Issues related to ensuring safe prescribing of opioids and other pharmaceuticals that can drive addiction. S. 3120 - Helping to End Addition and Lessen Substance Use Disorders Act - Issues related to ensuring safe prescribing of opioids and other pharmaceuticals that can drive addiction. S. 2460/H.R. 3528 - Every Prescription Conveyed Securely Act - support for a bill that would require electronic prescribing for opioids. CMS regulations related to the Medicare Part D program and role of Prescription Drug Plans. S. 637 - Creating Transparency to have Prescription Drug Rebates Unlocked - Issues related to the alleged relationship between rebates and drug prices. S. 771 - A bill to Improve Access to Affordable Prescription Drugs - Issues related to bringing drug pricing down including better policies in the Part D coverage gap, couponing and advancing biosimilars. H.R. 3447 - Furthering Access to Coordinated Treatment for Seniors (FACTS) Act of 2017 - Working to explain the need for safe and confidential data sharing between Medicare part A, B, and D to ensure better coordination of patient care. Issues related to Direct and Indirect Renumeration policies and their impact on consumers. The Trump Administration's Blueprint for Controlling Prescription Drug Prices - Issues related to the role PBMs can play in controlling the price of prescription medications in the United States.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 2553 - Know the Lowest Price Act of 2018- Support of the elimination of "gag clauses" in Medicare Part D. S. 2554 - Patient Right to Know Act - Support of the elimination of "gag clauses" in private market drug benefits. H.R. 6 - Support for Patients and Communities Act - Issues related to ensuring safe prescribing of opioids and other pharmaceuticals that can drive addiction. S. 3120 - Helping to End Addition and Lessen Substance Use Disorders Act - Issues related to ensuring safe prescribing of opioids and other pharmaceuticals that can drive addiction. S. 2460/H.R. 3528 - Every Prescription Conveyed Securely Act - support for a bill that would require electronic prescribing for opioids. CMS regulations related to the Medicare Part D program and role of Prescription Drug Plans. S. 637 - Creating Transparency to have Prescription Drug Rebates Unlocked - Issues related to the alleged relationship between rebates and drug prices. S. 771 - A bill to Improve Access to Affordable Prescription Drugs - Issue related to bringing drug pricing down including better policies in the Part D coverage gap, couponing and advancing biosimilars. H.R. 3447 - Furthering Access to Coordinated Treatment for Seniors (FACTS) Act of 2017 - Working to explain the need for safe and confidential data sharing between Medicare part A, B, and D to ensure better coordination of patient care. Issues related to Direct and Indirect Renumeration policies and their impact on consumers. The Trump Administration's Blueprint for Controlling Prescription Drug Prices - Issues related to the role PBMs can play in controlling the price of prescription medications in the United States.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 2553 - Know the Lowest Price Act of 2018- Support of the elimination of "gag clauses" in Medicare Part D. S. 2554 - Patient Right to Know Act - Support of the elimination of "gag clauses" in private market drug benefits. H.R. 6 - Support for Patients and Communities Act - Issues related to ensuring safe prescribing of opioids and other pharmaceuticals that can drive addiction. S. 3120 - Helping to End Addition and Lessen Substance Use Disorders Act - Issues related to ensuring safe prescribing of opioids and other pharmaceuticals that can drive addiction. S. 2460/H.R. 3528 - Every Prescription Conveyed Securely Act - support for a bill that would require electronic prescribing for opioids. CMS regulations related to the Medicare Part D program and role of Prescription Drug Plans. S. 637 - Creating Transparency to have Prescription Drug Rebates Unlocked - Issues related to the alleged relationship between rebates and drug prices. S. 771 - A bill to Improve Access to Affordable Prescription Drugs - Issue related to bringing drug pricing down including better policies in the Part D coverage gap, couponing and advancing biosimilars. H.R. 3447 - Furthering Access to Coordinated Treatment for Seniors (FACTS) Act of 2017 - Working to explain the need for safe and confidential data sharing between Medicare part A, B, and D to ensure better coordination of patient care. Issues related to Direct and Indirect Renumeration policies and their impact on consumers. The Trump Administration's Blueprint for Controlling Prescription Drug Prices - Issues related to the role PBMs can play in controlling the price of prescription medications in the United States.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to pharmaceutical manufacturer and pharmacy contracting with respect to drug pricing. Issues included in the Proposed Part D Rule and accompanying RFI and the Administrations Blueprint on drug pricing RFI . Issues related to Medicaid Provider Enrollment. Issues related to prescription drug abuse. Issues related to the Medicare Coverage Gap Discount. Regulatory design and coverage of pharmacy benefits in health reform exchanges and the commercial market (essential health benefits, e-prescribing, PBM disclosure requirements, specialty pharmacy, mail-service pharmacy, formulary transparency, and medical loss ratio). H.R.749/S.297, Lower Drug Costs through Competition Act HR.1038/S.413, Improving Transparency and Accuracy in Part D Spending Act H.R.1316, Prescription Drug Price Transparency Act S.637, Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017 S.771, Improving Access to Affordable Prescription Drug Act H.R.1939/S.1044, Ensuring Seniors Access to Local Pharmacies Act H.R. 2026, Pharmaceutical Information Exchange Act H.R.2051, FAST Generics Act H.R.2212/S.974, Creating and Restoring Equal Access To Equivalent Samples Act of 2017 H.R.2077 Restoring the Patient's Voice Act of 2017 S.2553/H.R.6144, Know the Lowest Price Act of 2018 S.2554/H.R.6143, Patient Right to Know Drug Prices Act H.R.3528/S.2460, The Every Prescription Carried Safely Act H.R.5343, Prescription Transparency Act of 2018 H.R.4841, Standardizing Electronic Prior Authorization for Safe Prescribing Act of 2018 Issues related to the affordability of prescription drugs and competitive marketplace, including: pedigree, manufacturer market and data exclusivity, REMS, accelerated generic approval, biosimilars.

Client expense: $656,680 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), SENATE

Issues related to pharmaceutical manufacturer and pharmacy contracting with respect to drug pricing. Regulatory and proposed legislative changes to Medicare Part D including non-interference, Direct and Indirect Remuneration (DIR), pharmacy networks, classes of clinical concern, mail-service pharmacy and safe harbors related to manufacturer rebates. Issues related to the management of Medicaid prescription drug benefits. Issues related to prescription drug abuse in Medicare and Medicaid. Provisions of PL 111-148 and PL 111-152 impacting Medicare Part D such as formulary requirements, PBM disclosure provisions, implementation of the prescriber registration rules and definition of negotiated price. Regulatory design and coverage of pharmacy benefits. Issues related to Medicaid Provider Enrollment. Issues related to the Medicare Coverage Gap Discount. H.R.1038/S.413, Improving Transparency and Accuracy in Part D Spending Act H.R.1316, Prescription Drug Price Transparency Act S.637, Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017 S.771, Improving Access to Affordable Prescription Drug ActH.R.1939/S.1044, Ensuring Seniors Access to Local Pharmacies ActH.R.3528/S.2460, The Every Prescription Carried Safely Act S.2553/H.R.6144, Know the Lowest Price Act of 2018 S.2554/H.R.6143, Patient Right to Know Drug Prices Act H.R.4841, Standardizing Electronic Prior Authorization for Safe Prescribing Act of 2018 H.R.5958, Fair Pricing Act of 2018 H.R.5343, Prescription Transparency Act of 2018

Client expense: $656,680 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), SENATE

Issues related to pharmacy contracting with respect to drug pricing and pharmacy networks. Regulatory and proposed legislative changes to Medicare Part D pharmacy contracting, Direct and Indirect Remuneration (DIR), pharmacy networks, and mail-service pharmacy. Issues included in the Part D Rule and accompanying RFI. Issues related to the management of Medicaid prescription drug benefits. Issues related to prescription drug abuse. Issues related to pharmacy gag clauses. HR.1038/S.413, Improving Transparency and Accuracy in Part D Spending Act H.R.1316, Prescription Drug Price Transparency Act S.637, Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017 S.771, Improving Access to Affordable Prescription Drug Act H.R.1939/S.1044, Ensuring Seniors Access to Local Pharmacies Act H.R.3528, The Every Prescription Carried Safely Act S.2553/H.R.6144, Know the Lowest Price Act of 2018 S.2554/H.R.6143, Patient Right to Know Drug Prices Act H.R.5343, Prescription Transparency Act of 2018 H.R.4841, Standardizing Electronic Prior Authorization for Safe Prescribing Act of 2018

Client expense: $656,680 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), SENATE

Monitor implementation of the Patient Protection and Affordable Care Act (P.L. 111-148). Monitor federal and legislative activity related to Medicare Reimbursement. Monitor federal issues and legislation associated with health care policy. Monitor implementation of Medicare Access and CHIP Reauthorization Act of 2015 (P.L. 114-10). Monitor implementation of 21st Century Cures Act (P.L. 114-255). H.R. 6, SUPPORT for Patients and Communities Act. H.R. 849, Protecting Seniors' Access to Medicare Act of 2017. H.R. 1038, Improving Transparency and Accuracy in Medicare Part D Spending Act. H.R. 1316, Prescription Drug Price Transparency Act. H.R. 1628, American Health Care Act of 2017. H.R. 1703, Medical Product Communications Act of 2017. H.R. 1898, To improve access to, and utilization of, bone mass measurement benefits. H.R. 1920, 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.2077, Restoring the Patient's Voice Act of 2017. H.R. 2141, Conrad State 30 and Physician Access Reauthorization Act. H.R. 2267, Resident Physician Shortage Reduction Act of 2017. H.R. 2641, Promoting Life-Saving New Therapies for Neonates Act of 2017. H.R. 2999, Patients' Access to Treatments Act of 2017. H.R. 3635, Local Coverage Determination Clarification Act of 2017. H.R. 3728, EMPOWER Act of 2017. H.R. 3767, Ensuring Children's Access to Specialty Care Act of 2017. H.R. 4841, Standardizing Electronic Prior Authorization for Safe Prescribing Act of 2018. H.R. 5150, Protecting Medicare from Excessive Price Increases Act of 2018. H.R.6157, Defense and Labor, Health and Human Services Consolidated Appropriations Act, 2019. H.R. 6470, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2019. S. 251, Protecting Medicare from Executive Action Act of 2017. S. 260, Protecting Seniors' Access to Medicare Act of 2017. S. 637, Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017. S. 794, Local Coverage Determination Clarification Act of 2017. S. 898, Conrad State 30 and Physician Access Reauthorization Act. S. 989, Ensuring Children's Access to Specialty Care Act of 2017. S. 1301, Resident Physician Shortage Reduction Act of 2017. S. 1304, A bill 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. S. 2553, Know the Lowest Price Act of 2018 (P.L. 115-262). S. 2554, Patient Right to Know Drug Prices Act (P.L. 115-263). S. 2908, To provide for electronic prior authorization under Medicare part D for covered part D drugs, and for other purposes. S. 3158, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2019. S. 3159, Department of Defense Appropriations Act, 2019. S. 3160, To improve access to, and utilization of, bone mass measurement benefits.

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

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

Monitor implementation of the Patient Protection and Affordable Care Act (P.L. 111-148). Monitor federal and legislative activity related to Medicare Reimbursement. Monitor federal issues and legislation associated with health care policy. Monitor implementation of Medicare Access and CHIP Reauthorization Act of 2015 (P.L. 114-10). Monitor implementation of 21st Century Cures Act (P.L. 114-255). H.R. 6, SUPPORT for Patients and Communities Act. H.R. 849, Protecting Seniors' Access to Medicare Act of 2017. H.R. 1038, Improving Transparency and Accuracy in Medicare Part D Spending Act. H.R. 1316, Prescription Drug Price Transparency Act. H.R. 1628, American Health Care Act of 2017. H.R. 1703, Medical Product Communications Act of 2017. H.R. 1898, To improve access to, and utilization of, bone mass measurement benefits. H.R. 1920, 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.2077, Restoring the Patient's Voice Act of 2017. H.R. 2141, Conrad State 30 and Physician Access Reauthorization Act. H.R. 2267, Resident Physician Shortage Reduction Act of 2017. H.R. 2641, Promoting Life-Saving New Therapies for Neonates Act of 2017. H.R. 2999, Patients' Access to Treatments Act of 2017. H.R. 3635, Local Coverage Determination Clarification Act of 2017. H.R. 3728, EMPOWER Act of 2017. H.R. 3767, Ensuring Children's Access to Specialty Care Act of 2017. H.R. 4841, Standardizing Electronic Prior Authorization for Safe Prescribing Act of 2018. H.R. 5150, Protecting Medicare from Excessive Price Increases Act of 2018. H.R.6157, Defense and Labor, Health and Human Services Consolidated Appropriations Act, 2019. H.R. 6470, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2019. S. 251, Protecting Medicare from Executive Action Act of 2017. S. 260, Protecting Seniors' Access to Medicare Act of 2017. S. 637, Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017. S. 794, Local Coverage Determination Clarification Act of 2017. S. 898, Conrad State 30 and Physician Access Reauthorization Act. S. 989, Ensuring Children's Access to Specialty Care Act of 2017. S. 1301, Resident Physician Shortage Reduction Act of 2017. S. 1304, A bill 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. S. 2553, Know the Lowest Price Act of 2018 (P.L. 115-262). S. 2554, Patient Right to Know Drug Prices Act (P.L. 115-263). S. 2908, To provide for electronic prior authorization under Medicare part D for covered part D drugs, and for other purposes. S. 3158, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2019. S. 3159, Department of Defense Appropriations Act, 2019. S. 3160, To improve access to, and utilization of, bone mass measurement benefits.

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

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