Patient Right to Know Drug Prices Act

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: $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

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

Issues related to health care, including employee health care plans, and the Patients Right to Know Drug Prices Act (H.R. 6143 / S. 2554).

Client expense: $3,710,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Consumer Financial Protection Bureau (CFPB), Consumer Product Safety Commission (CPSC), Defense, Dept of (DOD), Education, Dept of, Executive Office of the President (EOP), Federal Aviation Administration (FAA), Federal Communications Commission (FCC), Federal Reserve System, Federal Trade Commission (FTC), Food & Drug Administration (FDA), General Services Administration (GSA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Aeronautics & Space Administration (NASA), Natl Economic Council (NEC), Natl Institute of Standards & Technology (NIST), Natl Security Council (NSC), Natl Telecommunications & Information Administration (NTIA), Office of Management & Budget (OMB), Office of Personnel Management (OPM), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), Postal Regulatory Commission, SENATE, Small Business Administration (SBA), State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Copyright Office, U.S. Customs & Border Protection, U.S. Immigration & Customs Enforcement (ICE), U.S. Postal Service (USPS), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA), White House Office

H.R. 6, SUPPORT for Patients and Communities Act (passed House and Senate/signed into law October 24), provisions relating to drug safety and treatment and recovery issues H.R. 6082, Overdose Prevention and Safety Act, provisions relating to treatment and recovery and aligning privacy rules. Administration Request for Information, HHS Blueprint to lower drug prices and reduce out-of-pocket costs (docket number HHS-OS-2018-0010). Administration proposed rule submitted to OMB (not yet released except title). Removal of safe harbor protection for rebates to plans or PBMs involving prescription pharmaceuticals and creation of new safe harbor (HHS-OIG, RIN 0936-AA08) S. 2553 Know the Lowest Price Act of 2018 and S. 2554 Patient Right to Know Drug Prices Act (passed and signed into law on October 10), provisions relating to PBM rules.

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

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

H.R. 749: Lower Drug Costs through Competition Act - Provisions related to generic drug approvals H.R. 1245: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 1480: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation H.R. 1628: American Health Care Act of 2017 - Provisions related to the biopharmaceutical industry including repeal of brand pharmaceutical manufacturer fee and individual and employer mandates, insurance affordability provisions, and Medicaid reforms H.R. 1776: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing H.R. 2051: FAST Generics Act of 2017 - Provisions related to REMS and limited distribution systems H.R. 2212: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 4710: 340B Protecting Access for the Underserved and Safety-net Entities Act or PAUSE Act - Provisions related to the 340B program H.R. 5041: The Safe Disposal of Unused Medication Act - Provisions related to drug disposal H.R. 5228: SCREEN Act - Provisions related to drug recall authority H.R. 5311: CARA 2.0 Act of 2018 - Provisions to reauthorize and expand the Comprehensive Addiction and Recovery Act H.R. 5598: 340B Optimization Act - Provisions related to transparency in the 340B program H.R. 6574: Medicare Fair Drug Pricing Act of 2018 - Provisions related to drug pricing HR 5333 - Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018 S 2315 - Over-the-Counter Drug Safety, Innovation, and Reform Act HR 7328 - Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 HR 394/S85 - Restoring Access to Medication Ac HR 6199 - Restoring Access to Medication and Modernizing Health Savings Accounts Act of 2018 Medicare Doughnjt hole -House/Senate Labor HHS AppropriationsHouse/Senate DoD AppropriationsDoggett bill Trump Administration IPI proposal, Trump Administration proposed changes to six protected classes. HR6378, Pandemic and All Hazards Preparedness and Advancing Innovation Act; HR4993/S3253, Vaccine Access Improvement Act; HR 4297/S2103, Protecting Seniors Through Immunization Act; H.R.4710 - 340B PAUSE ActH.R.4297 - Protecting Seniors Through Immunization Act of 2017 S. 3477 - Protecting Seniors through Immunization Act S. 64: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 92: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 469: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 771: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing S. 974: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017 - Provisions related to drug pricing S. 2312: HELP Act - Provisions related to 340B program S. 2453: Ensuring the Value of the 340B Program Act of 2018 - Provisions to increase transparency in the 340B program S. 2553: Know the Lowest Price Act of 2018 - Provisions related to drug pricing S. 2554: Patient Right to Know Drug Prices Act - To ensure that health insurance issuers and group health plans do not prohibit pharmacy providers from providing certain information to enrollees -Know the Lowest Price Act of 2018Medicare Part D Six Protected Classes HHS Proposal on Medicare Part B International Pricing Index (IPI)340B Drug Discount Program S. 3519: A bill to establish a process for the Food and Drug Administration to determine whether to modify the labeling of drugs whose labeling may be outdated, including drugs with accepted uses that are not reflected in the approved labeling S. 3775: Affordable Drug Manufacturing Act of 2018 Drug cost and pricing policy issues Transparency policy issues Drug importation and counterfeiting policy issues Prescription drug take back and secure disposal policy issues Expanded access policy issues Generic drug approval process policy issues High deductible health plans/HSA policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues Compulsory licensing policy issues Foreign reference pricing policy issues 340B drug discount program policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions Biosimilar approval and reimbursement policy issues Drug compounding policy issues including federal oversight of compounded drugs Cancer drug vial size policy issues TRICARE pharmacy pilot program Drug shortages policy issues Reauthorization of the Pandemic and All-Hazards Preparedness Act Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (RIN 0991-ZA49)

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. 4117: Competitive Deals Resulting in Unleashed Generics and Savings Act of 2017 or the Competitive DRUGS Act of 2017 - Patent Settlements H.R. 5340: The Support Technology & Research for Our Nations Growth and Economic Resilience (STRONGER) Patents Act of 2018 - Provisions related to reforms of Patent Trial and Appeal Board (PTAB) proceedings and other patent system reforms S. 124: Preserve Access to Affordable Generics Act - Provisions related to patent settlements S. 1390: STRONGER Patents Act of 2017 - Provisions related to reforms of PTAB proceedings and other patent system reforms Biopharmaceutical innovation and patent policy issues Patent litigation reform issues and issues related to post-grant proceeding at the PTO S. 2554:Patient Right to Know Drug Prices Act - provisions related to notification of agreements to the FTC and DOJ

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.

Bipartisan Healthcare Stabilization Act (Alexander-Murray) Affordable Care Act Implementation H.R. 2026 Pharmaceutical Information Exchange Act H.R. 878, H.R. 2368, S. 204 Right-to-Try Legislation S. 2554, Patient Right to Know Drug Prices Act

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

Preserve Access to Affordable Generics Act (S. 124); Regulatory exclusivity; Improving Access To Affordable Prescription Drugs Act (S. 771/H.R. 1776); Drug pricing; SUPPORT for Patients and Communities Act (H.R. 6); Biosimilars Competition Act of 2018 (H.R. 6478); Patient Right to Know Drug Prices Act (S. 2554/H.R. 6143); Medicare Negotiation and Competitive Licensing Act of 2018 (H.R. 6505); Making Objective Drug Evidence Revisions for New (MODERN) Labeling Act (S. 3519); citizen petitions; Medicare Part B international reference pricing; Hatch-Waxman Integrity Act of 2018 (S. 3738/H.R. 7251); Affordable Drug Manufacturing Act of 2018 (H.R. 7348/S. 3775); Preserve Access to Affordable Generics and Biosimilars Act (S. 3792); Direct-to-consumer pharmaceutical advertising.

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

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

H.R. 6: SUPPORT for Patients and Communities Act - To provide for opioid use disorder prevention, recovery, and treatment, and for other purposes H.R. 449: Synthetic Drug Awareness Act: Provisions related to synthetic drug report H.R. 749: Lower Drug Costs through Competition Act - Provisions related to generic drug approvals H.R. 1245: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 1480: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation H.R. 1628: American Health Care Act of 2017 - Provisions related to the biopharmaceutical industry including repeal of brand pharmaceutical manufacturer fee and individual and employer mandates, insurance affordability provisions, and Medicaid reforms H.R. 1776: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing H.R. 2051: FAST Generics Act of 2017 - Provisions related to REMS and limited distribution systems H.R. 2063: Opioid Preventing Abuse through Continuing Education (PACE) Act of 2017 - Provisions related to prescriber training H.R. 2212: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 4710: 340B Protecting Access for the Underserved and Safety-net Entities Act or PAUSE Act - Provisions related to the 340B program H.R. 5041: The Safe Disposal of Unused Medication Act - Provisions related to drug disposal H.R. 5228: SCREEN Act - Provisions related to drug recall authority H.R. 5311: CARA 2.0 Act of 2018 - Provisions to reauthorize and expand the Comprehensive Addiction and Recovery Act H.R. 5598: 340B Optimization Act - Provisions related to transparency in the 340B program H.R. 6574: Medicare Fair Drug Pricing Act of 2018 - Provisions related to drug pricing S. 64: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 92: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 469: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 771: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing S. 974: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017 - Provisions related to drug pricing S. 2312: HELP Act - Provisions related to 340B program S. 2453: Ensuring the Value of the 340B Program Act of 2018 - Provisions to increase transparency in the 340B program S. 2553: Know the Lowest Price Act of 2018 - Provisions related to drug pricing S. 2554: Patient Right to Know Drug Prices Act - To ensure that health insurance issuers and group health plans do not prohibit pharmacy providers from providing certain information to enrollees S. 2665: A bill to require guidance on how the Food and Drug Administration will consider claims of opioid sparing and on the conditions under which the Food and Drug Administration will consider misuse and abuse of drugs in making certain determinations of safety S. 2680: Opioid Crisis Response Act of 2018 - Provisions related to opioids S. 3519: A bill to establish a process for the Food and Drug Administration to determine whether to modify the labeling of drugs whose labeling may be outdated, including drugs with accepted uses that are not reflected in the approved labeling S. 3775: Affordable Drug Manufacturing Act of 2018 Drug cost and pricing policy issues Transparency policy issues Drug importation and counterfeiting policy issues Prescription drug take back and secure disposal policy issues Policy issues related to prescription drug abuse and opioids Expanded access policy issues Generic drug approval process policy issues High deductible health plans/HSA policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues Compulsory licensing policy issues Foreign reference pricing policy issues 340B drug discount program policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions Biosimilar approval and reimbursement policy issues Drug compounding policy issues including federal oversight of compounded drugs Cancer drug vial size policy issues TRICARE pharmacy pilot program Drug shortages policy issues Reauthorization of the Pandemic and All-Hazards Preparedness Act Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (RIN 0991-ZA49)

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)

Medicare Advantage; Medicare Prior Authorization; Medicaid Rebates; Medicaid Expansion; Medicaid General; CHIP Reform; Medicare Access & CHIP Reauthorization Act of 2015 (MACRA); Rate Notice and Call Letter; Medicare Part D; Medicaid Alignment; NBPP, Part D Donut Hole, Rx Rebates, Patient's Act (Dialysis), ACE Kid's Act; Medicare Data Sharing HR 6 SUPPORT for Patients and Communities Act Introduced June 13, 2018 by Greg Walden (R-OR) includes Medicaid, Medicare, and public health reforms to combat the opioid crisis by advancing treatment and recovery initiatives, improving prevention, protecting communities, and bolstering efforts to combat illicit synthetic drugs like fentanyl. The policies contained in the legislation were advanced through regular order by the House Energy and Commerce Committee and the Ways and Means Committee. HR 3325 ACE Kids Act Introduced July 20, 2017 by Joe Barton (R-TX) To amend title XIX of the Social Security Act to provide States with the option of providing coordinated care for children with complex medical conditions through a health home, and for other purposes. HR 4143 Dialysis Patients Demonstration Act of 2017 Introduced October 26, 2017 by Jason Smith (R-MO) To establish a demonstration program to provide integrated care for Medicare beneficiaries with end-stage renal disease, and for other purposes. HR 6478 Biosimilars Competition Act of 2018 Introduced July 23, 2018 by John Sarbanes (D-MD) To enhance competition for prescription drugs by increasing the ability of the Department of Justice and Federal Trade Commission to enforce existing antitrust laws regarding biologic and biosimilar products, and for other purposes. S 2554 Patient Right to Know Drug Price Act of 2018 Introduced March 14, 2018 by Susan Collins (R-ME) Americans overspend by an estimated $135 million on prescriptions through their insurance, in cases when they would cost less out of pocket. Yet pharmacists are often under gag orders from telling customers about that discrepancy. A new bill introduced in the Senate would end this practice.

Client expense: $1,590,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Office of Personnel Management (OPM), Office of the Vice President of the United States, SENATE, Vice President of the U.S., White House Office

S. 297, Increasing Competition in Pharmaceuticals Act (Collins-McCaskill) - prescription drug costs S. 974, CREATES Act (Leahy-Grassley) - access to generic drugs and biosimilars S. 1115, Making Pharmaceutical Markets More Competitive Act (Collins-McCaskill) - accelerated approval of generic therapies S. 1131, FAIR Drug Pricing Act (Baldwin-McCain) - transparency in prescription drug pricing S. 2553, Know the Lowest Price Act (Stabenow) - pharmacist-patient communications S. 2554, Patient Right to Know Drug Prices Act (Collins) - pharmacist-patient communications, reporting of biosimilar pay-for-delay settlements S. 3194, Capping Prescription Costs Act (Warren) - capping prescription copays S. 3738, Hatch-Waxman Integrity Act (Hatch) - inter partes review process S. 3792, Preserve Access to Affordable Generics and Biosimilars Act (Klobuchar-Grassley) - pay-for-delay settlements H.R. 749, Lower Drug Costs Through Competition Act (Schrader-Bilirakis) - prescription drug costs H.R. 1703, Medical Product Communication Act (Griffith) - off-label exchange of information H.R. 2026, Pharmaceutical Information Exchange Act (Guthrie) - pre-approval health care economic information to payors H.R. 2051, Fair Access for Safe and Timely Generics Act (McKinley-Welch) - access to generic drugs H.R. 2212, CREATES Act (Marino-Cicilline) - access to generic drugs and biosimilars H.R. 2439, FAIR Drug Pricing Act (Schakowsky) - transparency in prescription drug pricing H.R. 2562, Making Pharmaceutical Markets More Competitive Act (Kelly) - accelerated approval of generic therapies H.R. 2999, Patients' Access to Treatments Act (McKinley) - limiting cost sharing in specialty drug tiers H.R. 5247, Right to Try Act (Fitzpatrick) - use of unapproved investigational drugs by patients with life-threatening conditions H.R. 6142, Reducing Drug Waste Act (Doggett) - packaging of medications H.R. 6157, Defense-Labor-HHS-Education Appropriations Act (Granger) -pharmaceutical price transparency in DTC advertising H.R. 6340, Capping Prescription Costs Act (Rosen) - capping prescription copays H.R. 6478, Biosimilars Competition Act (Sarbanes) - reporting of pay-for-delay settlements H.R. 6576, Drug-Price Transparency in Communications Act (Schakowsky) - disclosure of drug prices in DTC advertising H.R. 6733, Know the Cost Act (Carter) - pharmacist-patient communications H.R. 7251, Hatch-Waxman Integrity Act (Flores) - inter partes review process 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 related to pharmacy benefit managers; issues related to biosimilars; issues related to approval of drugs and biologics; issues relating to opioids; issues relating to prescription drug rebates; issues relating to prescription drug price blueprint; direct-to-consumer advertising for prescription drugs; issues relating to access for investigational drugs; and other issues relating to health care reform implementation.

Client expense: $1,540,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, Treasury, Dept of, White House Office

340B Drug Pricing Program Opioid issues (S. 2680, the Opioid Crisis Response Act of 2018; H.R. 5176, Preventing Overdoses While in Emergency Rooms (POWER) Act; H.R. 5197, Alternatives to Opioids (ALTO) in the Emergency Department Act; H.R. 5009, Jessies Law; H.R. 5818 / S. 2843, the Opioid Workforce Act; H.R. 5797, the IMD CARE Act; H.R. 6082/H.R. 5795, the Overdose Prevention and Patient Safety Act; S. 2905, Strengthening Partnerships to Prevent Opioid Abuse Act; S. 2460, Every Prescription Conveyed Securely Act; S. 2920, Commit to Opioid Medical Prescriber Accountability and Safety for Seniors Act; H.R. 5582, the Abuse Deterrent Access Act; H.R. 5685, the Medicare Opioid Safety Education Act; Helping to End Addiction and Lessen (HEAL) Substance Use Disorders Act of 2018; H.R. 6, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act; S. 2899, Caring Recovery for Infants and Babies Act; S. 2898, Medication-Assisted Treatment Improvement Act; S.2911, Enhancing Patient Access to Non-Opioid Treatment Options) Draft Protecting Patients from Surprise Medical Bills Act HIPAA policy in mental and behavioral health information sharing 21st Century Cures Act implementation Pandemic and All Hazards Preparedness Reauthorization, including Hospital Preparedness Program (S. 2852 / H.R. 6378, H.R. 7328, the Pandemic and All-Hazards Preparedness and Advancing Innovation Act (PAHPAI) of 2018) S.781/ HR 1876. Good Samaritan Health Professional Act of 2017 Health workforce reauthorizations (H.R. 959, the Title VIII Nursing Workforce Reauthorization Act; H.R. 3728, the Educating Medical Professionals and Optimizing Workforce Efficiency Readiness (EMPOWER) Act; H.R. 1676, the Palliative Care and Hospice Education and Training Act Liver allocation policy S.2554, Patient Right to Know Drug Prices Act Consumer-directed health care proposals (Associations Health Plans, Short-term Limited Duration Insurance plans, Section 1332 waivers) Maternal health legislation (H.R. 315, Improving Access to Maternity Care Act and H.R. 1318, Preventing Maternal Deaths Act)

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

Government targets: 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

Design and coverage of pharmacy benefits in Exchanges and the commercial market, including: eRx, EPCS, electronic prior authorization, PBM disclosure, MLR, and specialty pharmacy tiering. Implementation of biosimilars pathway from BPCIA. Policies placing restrictions on pharmacy benefit design. Issues relating to prescription drug affordability. REMS reform. Prescription drug user fee reauthorization. HR 1854; S 788; HR 2025; S 2553 and S 2554; HR 6.

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

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

Prescription drug pricing. S. 974 - CREATES Act. S. 1131 and H.R. 2439 - Fair Accountability and Innovative Research Drug Pricing Act H.R. 2051 - FAST Generics Act of 2017. Medicare Part D Biosimilars. H.R.6 - SUPPORT for Patients and Communities Act. S. 3120 - HEAL Act of 2018. S. 2553: Know the Lowest Price Act of 2018. S. 2554: Patient Right to Know Drug Prices Act.

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

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

Prescription drug pricing. S. 974 - CREATES Act. S. 1131 and H.R. 2439 - Fair Accountability and Innovative Research Drug Pricing Act H.R. 2051 - FAST Generics Act of 2017 Medicare Part D Biosimilars. H.R.6 - SUPPORT for Patients and Communities Act. S. 2553: Know the Lowest Price Act of 2018. S. 2554: Patient Right to Know Drug Prices Act.

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

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

Prescription drug pricing. Medicare Part D Biosimilars. H.R.6 - SUPPORT for Patients and Communities Act. S. 2553: Know the Lowest Price Act of 2018. S. 2554: Patient Right to Know Drug Prices Act.

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

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

H.R. 1408, Access to Insurance for All Americans Act H.R. 1628, American Health Care Reform Act H.R. 2400, to Allow Persons not Federal Employees to enroll in FEHBP H.R. 5965, Access to Infertility Treatment and Care Act S. 2960, Access to Infertility Treatment and Care Act H.R. 6143, Patient Right to Know Drug Prices Act S. 2554, Patient Right to Know Drug Prices Act H.R. 6733, Know the Cost Act of 2018

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

Government targets: Commodity Futures Trading Commission (CFTC), Consumer Financial Protection Bureau (CFPB), Federal Communications Commission (FCC), Federal Retirement Thrift Investment Board, Food & Drug Administration (FDA), General Services Administration (GSA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Merit Systems Protection Board, Natl Park Service (NPS), Office of Management & Budget (OMB), Office of Personnel Management (OPM), Office of Special Counsel, Office of the Comptroller of the Currency (OCC), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), Treasury, Dept of, U.S. Customs & Border Protection

H.R. 2212/ S. 974, CREATES Act - Discussed support of bill. H.R. 2439/S.1131, FAIR Drug Pricing Act - Discussed support of bill. S. 124, The Preserve Access to Affordable Generics Act - Discussed support of bill. Part D Deal in Bipartisan Budget Act, met with House and Senate offices to reiterate our support for the deal; sent multiple letters to House and Senate leadership; discussed support for the deal with House and Senate staff. Discussed the Presidents Prescription Drug Blueprint and RFI. S. 2553, Know the Lowest Price Act - supported passage of legislation. S.2554, Patient Right to Know Act - supported passage of legislation. Discussed possible ways to improve Medicare Part D. Discussed Rx Price Watch Reports and the impact of high drug costs. Discussed drug pricing reforms AARP supports, including secretarial negotiation, importation, reducing exclusivity for biologics, and ending pay-for-delay deals. Discussed Rx issues with HHS.

Client expense: $2,140,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Equal Employment Opportunity Commission (EEOC), Federal Highway Administration (FHA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Natl Highway Traffic Safety Administration (NHTSA), SENATE, Securities & Exchange Commission (SEC), Treasury, Dept of, White House Office

H.R. 246 - Jobs and Premium Protection Act. ACA Implementation, Medicare Advantage, Prescription Drugs. S. 1859 - Healthcare Tax Relief Act. S. 1978 - Small Business and Family Health Tax Relief Act of 2017. H.R. 4620 - Protecting Families and Small Businesses Act of 2017. Request for Information 0991-ZA49, HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R. 6 - SUPPORT for Patients and Communities Act. S. 3120 - HEAL Act of 2018. S. 2554 - Patient Right to Know Drug Prices Act. H.R. 878; H.R. 2368/S. 204 - Right-to-Try Legislation.

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

H.R. 7217 - IMPROVE Act; H.R. 3325/S. 428; Issues pertaining to Part D rebates; 2020 NBPP. H.R. 3325/S. 428 - "ACE Kids Act" - to amend title XIX of the Social Security Act to provide states with the option of providing coordinated care for children with complex medical conditions through a health home, regarding all provisions. S. 2554 - "Patients' Right to Know Drug Price Act of 2018", issues pertaining to drug pricing.

Client expense: $1,280,000 · Firm income: Not reported

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

Monitor and advocate on legislative and regulatory issues regarding healthcare. Legislative monitoring and outreach related to the H.R. 6, SUPPORT for Patients and Communities Act (P.L. 115-271). H.R. 6071, SERV Communities Act. H.R. 6082, Overdose Prevention and Patient Safety Act. Legislative monitoring and outreach related to the H.R. 6157, Department of Defense and Labor, Health and Human Services, and Education Appropriations Act, 2019 and Continuing Appropriations Act, 2019 (P.L. 115-245). H.R. 6733, Know the Cost Act of 2018. H.R. 7052, No Federal Funds for Public Charge Act of 2018. H.R. 7217, IMPROVE Act. S. 2553, Know the Lowest Price Act of 2018. S. 2554, Patient Right to Know Drug Prices Act. S. 2680, Opioid Crisis Response Act of 2018. S. 3120, HEAL Act of 2018. S. 3702, Right Rebate Act of 2018.

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

Government targets: HOUSE OF REPRESENTATIVES

Legislative Opioids Crisis Response Act - S. 2680/H.R. 6 Health Care Reform - ongoing legislative and regulatory implementation of the Patient Protection and Affordable Care Act (ACA), Cadillac tax on health benefits Continuing Appropriations Act of 2018 - H.J. Res. 125 - two year delay of the Cadillac Tax Middle Class Health Benefits Tax Repeal Act of 2017 - S. 58/H.R. 173 Health Savings Act of 2017 - S. 403/H.R. 1175 Creating High Quality-Results and Outcomes Necessary to Improve Chronic (CHRONIC) Care Act - S. 870 Save American Workers Act - H.R. 3798 Chronic Disease Management Act of 2018 - S. 2410/H.R. 4978 Broader Options for Americans Act - H.R. 2579 Commonsense Reporting Act of 2017 - S. 1908/H.R. 3919 Workflex in the 21st Century Act - H.R. 4219 ACA Relief Legislation - H.R. 4616 Bipartisan HSA Improvements Act of 2018 - H.R. 5138 HSA Employer Flexibility Act - H.R. 6128 Restoring Access to Medication and Modernizing Health Savings Accounts Act - S. 6199 Increasing Access to Lower Premium Plans and Expanding Health Savings Accounts Act - H.R. 6311 Patient Right to Know Drug Prices Act - S. 2554 Paid Family Leave Pilot Extension Act of 2018 - S. 3412 Reducing Costs for Out-of-Network Service Act of 2018 - S. 3541 No More Surprise Medical Bills Act of 2018 - S. 3592 Retirement, Savings, and Other Tax Relief Act of 2018 Protecting Patients from Surprise Medical Bills Act - Legislative Discussion Draft The Bipartisan Budget Act of 2018 Consolidated Appropriations Act of 2018 Fiscal Year 2019 budget proposal - provisions affecting employer-sponsored benefits Cost transparency and out-of-network billing Regulatory and Other Cost transparency Association Health Plans (AHPs) Health Reimbursement Accounts (HRAs) - Proposed regulations to use HRAs to purchase health insurance on the individual markets High Deductible Health Plans (HDHPs) Health Savings Accounts (HSAs) Department of Health & Human Services - Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs Federal disaster tax, filing and reporting relief for employers and individuals Presidential Executive Order: Reducing Regulation and Controlling Regulatory Cost Presidential Executive Order: Minimizing the Economic Burden of the Patient Protection and Affordable Care Act Pending Repeal Presidential Executive Order Promoting Healthcare Choice and Competition Across the United States - STLDI Employer wellness programs - nondiscrimination rules: Americans with Disabilities ACT (ADA) & Genetic Information Nondiscrimination Act (GINA) - Final regulations Medicare Advantage Program State health care requirements affecting self-insured plans FAQs - proposed guidance regarding implementation the Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA) - as amended by the Affordable Care Act (ACA) and the 21st Century Cures Act Electronic communication and disclosure of benefits information Paid leave proposals and issues

Client expense: $286,066 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Equal Employment Opportunity Commission (EEOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Pension Benefit Guaranty Corporation (PBGC), SENATE, Securities & Exchange Commission (SEC), Treasury, Dept of, White House Office

Medicare Advantage; Medicare Prior Authorization; Medicaid Rebates; Medicaid Expansion; Medicaid General; CHIP Reform; Medicare Access & CHIP Reauthorization Act of 2015 (MACRA); Medicare Part D; Medicaid Alignment; Part D Donut Hole, Rx Rebates, Patients Act (Dialysis), ACE Kids Act. HR 6 SUPPORT for Patients and Communities Act Introduced June 13, 2018 by Greg Walden (R-OR) includes Medicaid, Medicare, and public health reforms to combat the opioid crisis by advancing treatment and recovery initiatives, improving prevention, protecting communities, and bolstering efforts to combat illicit synthetic drugs like fentanyl. The policies contained in the legislation were advanced through regular order by the House Energy and Commerce Committee and the Ways and Means Committee. HR 3325 ACE Kids Act Introduced July 20, 2017 by Joe Barton (R-TX) To amend title XIX of the Social Security Act to provide States with the options of providing coordinated care for children with complex medical conditions through a health home, and for other purposes. HR 4143 Dialysis Patients Demonstration Act of 2017 Introduced October 26, 2017 by Jason Smith (R-MO) To establish a demonstration program to provide integrated care for Medicare beneficiaries with end-stage renal disease, and for other purposes. HR 6478 Biosimilars Competition Act of 2018 Introduced July 23, 2018 by John Sarbanes (D-MD) To enhance competition for prescription drugs by increasing the ability of the Department of Justice and Federal Trade Commission to enforce existing antitrust laws regarding biologic and biosimilar products, and for other purposes. S 2554 Patient Right to Know Drug Price Act of 2018 Introduced March 14, 2018 by Susan Collins (R-ME) Americans overspend by an estimated $135 million on prescriptions through their insurance, in cases when they would cost less out of pocket. Yet pharmacists are often under gag orders from telling customers about that discrepancy. A new bill introduced in the Senate would end this practice.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Legislative and regulatory issues including: Health care reform Implementation of the Affordable Care Act -- PL 111-148 Bipartisan Budget Act of 2018 -- H.R. 1892/PL 115-123 Middle Class Health Benefits Tax Repeal Act of 2017 - S. 58/H.R. 173 Save American Workers Act -- H.R. 3798 Restoring Access to Medication and Modernizing Health Savings Accounts Act (H.R. 6199) Increasing Access to Lower Premium Plans and Expanding Health Savings Accounts Act (H.R. 6311) Health Savings Act of 2017 - S. 403/H.R. 1175 Chronic Disease Management Act - S. 2410/H.R. 4978 Bipartisan HSA Improvement Act of 2018 - H.R. 5138/H.R. 6305 Mental Health Parity H.R. 6301, to provide high deductible health plans with first dollar coverage flexibility H.R. 6317, to provide that direct primary care service arrangements do not disqualify deductible health savings account contributions H.R. 6309, to allow individuals entitled to Medicare Part A by reason of being over age 65 to contribute to health savings accounts H.R. 6306, to increase the contribution limitation for health savings accounts, and for other purposes H.R. 4616, to provide for a temporary moratorium on the employer mandate and to provide for a delay in the implementation of the excise tax on high cost employer-sponsored health coverage H.R. 6, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act S. 2554, the Patient Right to Know Drug Prices Act S. 2553, the Know the Lowest Price Act HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs, RIN 0991-ZA49

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

Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Natl Economic Council (NEC), SENATE, Treasury, Dept of

Legislative and regulatory issues including: Health care reform Implementation of the Affordable Care Act -- PL 111-148 Bipartisan Budget Act of 2018 -- H.R. 1892/PL 115-123 Middle Class Health Benefits Tax Repeal Act of 2017 - S. 58/H.R. 173 Save American Workers Act -- H.R. 3798 Restoring Access to Medication and Modernizing Health Savings Accounts Act (H.R. 6199) Increasing Access to Lower Premium Plans and Expanding Health Savings Accounts Act (H.R. 6311) Health Savings Act of 2017 - S. 403/H.R. 1175 Chronic Disease Management Act - S. 2410/H.R. 4978 Bipartisan HSA Improvement Act of 2018 - H.R. 5138/H.R. 6305 Mental Health Parity H.R. 6301, to provide high deductible health plans with first dollar coverage flexibility H.R. 6317, to provide that direct primary care service arrangements do not disqualify deductible health savings account contributions H.R. 6309, to allow individuals entitled to Medicare Part A by reason of being over age 65 to contribute to health savings accounts H.R. 6306, to increase the contribution limitation for health savings accounts, and for other purposes H.R. 4616, to provide for a temporary moratorium on the employer mandate and to provide for a delay in the implementation of the excise tax on high cost employer-sponsored health coverage H.R. 6, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act S. 2554, the Patient Right to Know Drug Prices Act S. 2553, the Know the Lowest Price Act HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs, RIN 0991-ZA49

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

Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Natl Economic Council (NEC), SENATE, Treasury, Dept of

Medicare Advantage; Medicare Prior Authorization; Medicaid Expansion; Medicaid General; CHIP Reform; Medicare Access & CHIP Reauthorization Act of 2015 (MACRA); Rate Notice and Call Letter; Medicare Part D; NBPP, Part D Donut Hole, Rx Rebates, Patient's Act (Dialysis) HR 6 SUPPORT for Patients and Communities Act Introduced June 13, 2018 by Greg Walden (R-OR) includes Medicaid, Medicare, and public health reforms to combat the opioid crisis by advancing treatment and recovery initiatives, improving prevention, protecting communities, and bolstering efforts to combat illicit synthetic drugs like fentanyl. The policies contained in the legislation were advanced through regular order by the House Energy and Commerce Committee and the Ways and Means Committee. HR 4143 Dialysis Patients Demonstration Act of 2017 Introduced October 26, 2017 by Jason Smith (R-MO) To establish a demonstration program to provide integrated care for Medicare beneficiaries with end-stage renal disease, and for other purposes. HR 6478 Biosimilars Competition Act of 2018 Introduced July 23, 2018 by John Sarbanes (D-MD) To enhance competition for prescription drugs by increasing the ability of the Department of Justice and Federal Trade Commission to enforce existing antitrust laws regarding biologic and biosimilar products, and for other purposes. S 2554 Patient Right to Know Drug Price Act of 2018 Introduced March 14, 2018 by Susan Collins (R-ME) Americans overspend by an estimated $135 million on prescriptions through their insurance, in cases when they would cost less out of pocket. Yet pharmacists are often under gag orders from telling customers about that discrepancy. A new bill introduced in the Senate would end this practice.

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Prescription drug pricing. S. 974 - CREATES Act. S. 1131 and H.R. 2439 - Fair Accountability and Innovative Research Drug Pricing Act H.R. 2051 - FAST Generics Act of 2017 Medicare Part D Biosimilars. H.R.6 - SUPPORT for Patients and Communities Act. S. 2553: Know the Lowest Price Act of 2018. S. 2554: Patient Right to Know Drug Prices Act.

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

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

Prescription drug pricing. Medicare Part D Biosimilars. H.R.6 - SUPPORT for Patients and Communities Act. S. 2553: Know the Lowest Price Act of 2018. S. 2554: Patient Right to Know Drug Prices Act.

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

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

Prescription drug pricing. S. 974 - CREATES Act. S. 1131 and H.R. 2439 - Fair Accountability and Innovative Research Drug Pricing Act H.R. 2051 - FAST Generics Act of 2017. Medicare Part D Biosimilars. H.R.6 - SUPPORT for Patients and Communities Act. S. 3120 - HEAL Act of 2018. S. 2553: Know the Lowest Price Act of 2018. S. 2554: Patient Right to Know Drug Prices Act.

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

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

H.R.5723 - Expanding Oversight of Opioid Prescribing and Payment Act of 2018 H.R.5739 - Prescription Drug and Medical Device Price Review Board Act of 2018 S.2981 - Opioid Overdose Reduction Act of 2018 H.R.6143 - Patient Right to Know Drug Prices Act H.R.6133 - Informing Opioid Prescribing Through Evidence-Based Guidelines Act of 2018 S. 2554 - Patient Right to Know Drug Prices Act S. 2553 - Know the Lowest Price Act of 2018

Client expense: $330,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), SENATE, Treasury, Dept of, White House Office

H.R.6261 - Improving Choices in Health Care Coverage Act S.3095 - Building a Health Care Workforce for the Future Act H.R.6128 - HSA Employer Flexibility Act H.R.6110 - Dr. Todd Graham Pain Management, Treatment, and Recovery Act of 2018 H.R.6098 - Family Medical Leave Modernization Act H.R.6097 - State-Based Universal Health Care Act of 2018 H.R.6082 - Overdose Prevention and Patient Safety Act H.R.6 - SUPPORT for Patients and Communities Act S.3063 - Health Insurance Tax Relief Act of 2018 H.R.6071 - SERV Communities Act S.3053 - CHIP Mental Health and Addiction Parity Act S.3048 - Examining Opioid Treatment Infrastructure Act of 2018 H.R.6050 - Increasing Access to Care Act S.3016 - Action for Dental Health Act of 2018 S.3000 - Patient Advocacy Transparency Act H.R.5997 - Ensuring Patient Access to Critical Breakthrough Products Act of 2018 H.Res.915 - Expressing the sense of the Congress in support of protecting patients' access to medically appropriate, evidence-based healthcare and information, and the ethical and professional obligations of healthcare professionals to provide that care and information H.R.5966 - Women Veterans Access to Quality Care Act of 2018 H.R.5965 - Access to Infertility Treatment and Care Act H.R.5963 - To delay the reimposition of the annual fee on health insurance providers until after 2020 S.2960 - Access to Infertility Treatment and Care Act S.Res.526 - A resolution expressing the sense of the Senate that politicians should not interfere with a woman's personal health care decisions or attempt to prevent providers from offering their full medical recommendations to their patients H.R.5942 - Health Equity and Accountability Act of 2018 H.R.5933 - Substance Abuse Prevention Act of 2018 H.R.5932 - Increasing Access to Mental Health in Schools Act H.R.5925 - CRISIS Act S.2934 - Increasing Access to Mental Health in Schools Act H.R.5917 - Professional's Access to Health Workforce Integration Act of 2018 H.R.5914 - To require a study and report on policy and regulatory changes that may have contributed to the opioid epidemic S.2920 - Commit to Opioid Medical Prescriber Accountability and Safety for Seniors Act of 2018 S.2912 - Opioid Addiction Treatment Programs Enhancement Act H.R.6144 - Know the Lowest Price Act of 2018 S.204 - Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 S.2680 - Opioid Crisis Response Act of 2018 H.R.5511 - Healthy Communities Act of 2018 H.R.5491 - Rural Health Insurance Act of 2018 H.R.5455 - Accelerating Biomedical Research Act H.R.5641 - State Offices of Rural Health Reauthorization Act of 2018 H.R.5625 - Easy Enrollment Act of 2018 H.R.5624 - Pathway to Universal Coverage Act of 2018 H.R.5603 - Access to Telehealth Services for Substance Use Disorders Act S.2732 - Defending Access to Mental Health Care Act H.R.5699 - HOST Act of 2018 S.2802 - Responsible Additions and Increases to Sustain Employee Health Benefits Act of 2018 H.R.5725 - BEST Act S.2902 - Better Data Sharing to Combat the Opioid Crisis Act S.2901 - eTREAT Act H.R.5892 - To establish an Advisory Committee on Opioids and the Workplace to advise the Secretary of Labor on actions the Department of Labor can take to address the impact of opioid abuse on the workplace H.R.5858 - Primary Care Patient Protection Act of 2018 S.2875 - COMBAT Act of 2018 H.R.5795 - Overdose Prevention and Patient Safety Act S.2851 - Regional Health Care Emergency Preparedness and Response Systems Act H.R.5775 - Providing Reliable Options for Patients and Educational Resources Act of 2018 H.R.5769 - Expanding Access to Treatment Act S. 2608 - Reducing Opioid Risk Act S. 2589 - Comprehensive Opioid Recovery Centers Act of 2018 S. 2582 - Consumer Health Insurance Protection Act of 2018 S. 2554 - Patient Right to Know Drug Prices Act H.R. 5258 - Affordable Health Insurance for the Middle Class Act H.R. 5254 - To direct the Secretary of HHS to conduct a study on the feasibility of expanding eligibility for enrollment in Medicare Advantage plans to individuals enrolled under the Medicaid program or enrolled under a group health plan H.R. 5223 - Health Care Workplace Violence Prevention Act S. 2507 - Improving Choice in Health Care Coverage Act H.R. 5155 - Undo Sabotage and Expand Affordability of Health Insurance Act of 2018 S. 2496 - Small Business Health Account Act of 2018 S. 2494 - Fair Care Act H.R. 5138 - Bipartisan HSA Improvement Act of 2018 H.R. 5124 - Community Action Opioid Response Act of 2018 H.R. 5097 - PAVE Act of 2018 H.R. 5080 - COMBAT Act of 2018 H.R. 5062 - Advancing Access to Precision Medicine Act H.R. 5047 - VA Community Care Enhancement Act S. 2437 - Opioid Response Enhancement Act S. 2415 - Accelerating Kids Access to Care Act H.R. 4978 - Chronic Disease Management Act of 2018 S. 2410 - Chronic Disease Management Act of 2018 H.R. 4952 - To direct the Secretary of HHS to conduct a study and submit a report on the effects of the inclusion of quality increases in the determination of blended benchmark amounts under part C of the Medicare program H.R. 4938 - Respond NOW Act H.R. 4894 - Harmful Tax Prevention Act H.R. 4841 - Standardizing Electronic Prior Authorization for Safe Prescribing Act of 2018 H.R. 4831 - Healthcare Tax Relief Act H.R. 4820 - ASK Act S. 2315 - Over-the-Counter Drug Safety, Innovation, and Reform Act H.R. 4808 - Transparent Health Care Pricing Act of 2018 S. 2312 - HELP Act H.R. 4784 - ACA OUTREACH Act H.R. 4778 - Behavioral Health Coverage Transparency Act of 2018 S. 2302 - Access to Independent Health Insurance Advisors Act of 2018 S. 2301 - Behavioral Health Coverage Transparency Act of 2018 H.R. 4575 - A bill to amend title XXVII of the Public Health Service Act to preserve consumer and employer access to licensed independent insurance producers. S. 2303 - A bill to amend title XXVII of the Public Health Service Act to preserve consumer and employer access to licensed independent insurance producers. H.R. 1625 - Consolidated Appropriations Act, 2018 S. 2553 - Know the Lowest Price Act of 2018 H.R. 5343 - Prescription Transparency Act of 2018 H.R. 5150 - Protecting Medicare from Excessive Price Increases Act of 2018 H.R. 4874 - End The Shutdown Act of 2018 H.R. 4872 - End The Shutdown Act of 2018 H.R. 5104 - A bill to amend title XVIII of the Social Security Act to provide for a special enrollment period under Medicare for individuals enrolled in COBRA continuation coverage, and for other purposes H.R. 6 - SUPPORT for Patients and Communities Act S. 2554 - Patient Right to Know Drug Prices Act S. 2553 - Know the Lowest Price Act of 2018 H.R. 302 - FAA Re authorization Act of 2018 H. R. 6662 - Empowering Seniors Enrollment Decision Act of 2018 H.R. 6305 - Bipartisan HSA Improvement Act of 2018 H.R. 6312 - Personal Health Investment Today (PHIT) Act H.R. 6309 - To amend the Internal Revenue Code of 1986 to allow individuals entitled to Medicare Part A by reason of being over age 65 to contribute to health savings accounts H.R. 4616 - To amend the Patient Protection and Affordable Care Act to provide for a temporary moratorium on the employer mandate and to provide for a delay in the implementation of the excise tax on high cost employer-sponsored health coverage H.R. 6311 - To amend the Internal Revenue Code of 1986 and the Patient Protection and Affordable Care Act to modify the definition of qualified health plan for purposes of the health insurance premium tax credit and to allow individuals purchasing health insurance in the individual market to purchase a lower premium copper plan

Client expense: $330,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), SENATE, Treasury, Dept of, White House Office

1 and 2.) Federal Legislation and Issues (H.R. designates work with House of Representatives; S. designates work with Senate) H.R. 5768/S. 3366, the Expanding Access to Diabetes Self-Management Training (DSMT) Act. The Association supports this legislation to reduce barriers and increase the utilization of DSMT, which is a covered benefit under Medicare. S. 2554, the Patient Right to Know Drug Prices Act. The Association supports this legislation which would prohibit pharmacy gag clauses in contracts between a pharmacy and an insurer or pharmacy benefit manager (PBM). S.3592, the No More Surprise Medical Bills Act of 2018. At the request of Senator Maggie Hassans office, the Association provided feedback on this legislation which seeks to help people avoid paying large and unnecessary medical bills.

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

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE

H.R. 1038/S. 413 - Improving Transparency and Accuracy in Medicare Part D Spending Act H.R.592/S. 109 - Pharmacy and Medically Underserved Areas Enhancement Act H.R. 1316 - Prescription Drug Price Transparency Act H.R. 623 - Fairness to Pet Owners Act Letter to HHS/CMS on direct and indirect remuneration (DIR) fees Discussions with House committees on pharmacy benefit managers (PBMs) H.R.6 - SUPPORT for Patients and Communities Act - FDA Guidelines Section 3004 Letter S. 2680 - Opioid Crisis Response Act of 2018 H.R. 6733, Know the Cost Act of 2018 S. 2553, Know the Lowest Price Act S. 2554, the Patient Right to Know Drug Prices Act H.R. 5333, the Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018

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

Government targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Federal Reserve System, HOUSE OF REPRESENTATIVES, SENATE

Authority of Health Care Providers To Practice Telehealth The Medicare Part D Six Protected Class Drugs The International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) system amendments regarding Parkinson's disease "OFF" episodes. S.2553, the Know the Lowest Price Act of 2018, which prohibits restrictions, known as gag clauses, so that pharmacists will be free to provide important guidance to patients regarding how to effectively minimize their prescription drug costs S.2554, the Patient Right to Know Drug Prices Act, which prohibits restrictions, known as gag clauses, so that pharmacists will be free to provide important guidance to patients regarding how to effectively minimize their prescription drug costs Medicare drug formulary flexibility General drug pricing H.R. 5634, Medical Cannabis Research Act of 2018, which allows for an increased number of manufacturers of cannabis for research purposes. H.R.6502, the RUSH Act of 2018, which would establish a program to allow qualified group practices to furnish certain items and services at qualified skilled nursing facilities to individuals entitled to benefits under part A and enrolled under part B of the Medicare program to reduce unnecessary hospitalizations, and for other purposes. DAT-SPECT imaging with I-123 Ioflupane SPECT diagnostic imaging S.3657, the Traumatic Brain Injury (TBI) Program Reauthorization Act of 2018

Client expense: $17,000 · Firm income: Not reported

Government targets: Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), SENATE

Authority of Health Care Providers To Practice Telehealth The Medicare Part D Six Protected Class Drugs The International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) system amendments regarding Parkinson's disease "OFF" episodes. Medicare drug formulary flexibility General drug pricing Drug Pricing Request for Information S.2553, the Know the Lowest Price Act of 2018, which prohibits restrictions, known as gag clauses, so that pharmacists will be free to provide important guidance to patients regarding how to effectively minimize their prescription drug costs S.2554, the Patient Right to Know Drug Prices Act, which prohibits restrictions, known as gag clauses, so that pharmacists will be free to provide important guidance to patients regarding how to effectively minimize their prescription drug costs H.R.6502, the RUSH Act of 2018, which would establish a program to allow qualified group practices to furnish certain items and services at qualified skilled nursing facilities to individuals entitled to benefits under part A and enrolled under part B of the Medicare program to reduce unnecessary hospitalizations, and for other purposes.

Client expense: $17,000 · Firm income: Not reported

Government targets: Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), SENATE

Medicare Advantage; Medicare Prior Authorization; Medicaid Rebates; Medicaid Expansion; CHIP Reform; Medicare Access & CHIP Reauthorization Act of 2015 (MACRA); Rate Notice and Call Letter; Medicare Part D; Patient's Act (Dialysis); Part D Donut Hole; Prescription Drug Rebates; ACE Kid's Act HR 6 Introduced June 13, 2018 by Greg Walden (R-OR). The SUPPORT for Patients and Communities Act includes Medicaid, Medicare, and public health reforms to combat the opioid crisis by advancing treatment and recovery initiatives, improving prevention, protecting communities, and bolstering efforts to combat illicit synthetic drugs like fentanyl. The policies contained in the legislation were advanced through regular order by the House Energy and Commerce Committee and the Ways and Means Committee. HR 3325 Introduced July 20, 2017 by Joe Barton (R-TX). This bill amends title XIX of the Social Security Act to provide states with the option of providing coordinated care for children with complex medical conditions through a health home, and for other purposes. HR 4143 Introduced October 26, 2017 by Jason Smith (R-MO). The Dialysis Patients Demonstration Act of 2017 establishes a demonstration program to provide integrated care for Medicare beneficiaries with end-stage renal disease, and for other purposes. HR 6478 Introduced July 23, 2018 by John Sarbanes (D-MD). The Biosimilars Competition Act of 2018 enhances competition for prescription drugs by increasing the ability of the Department of Justice and Federal Trade Commission to enforce existing antitrust laws regarding biologic and biosimilar products, and for other purposes. S 2554 Introduced March 14, 2018 by Susan Collins (R-ME). The Patient Right to Know Drug Price Act of 2018. Americans overspend by an estimated $135 million on prescriptions through their insurance, in cases where their drugs would cost less out of pocket. Yet pharmacists are often under gag orders from telling customers about that discrepancy. This bill would end this practice.

Client expense: $5,500 · Firm income: Not reported

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

Medicare Advantage; Medicare Prior Authorization; Medicaid Rebates; Medicaid Expansion; CHIP Reform; Medicare Access & CHIP Reauthorization Act of 2015 (MACRA); Rate Notice and Call Letter; Medicare Part D; Patient's Act (Dialysis); Part D Donut Hole; Prescription Drug Rebates; ACE Kid's Act HR 6 Introduced June 13, 2018 by Greg Walden (R-OR). The SUPPORT for Patients and Communities Act includes Medicaid, Medicare, and public health reforms to combat the opioid crisis by advancing treatment and recovery initiatives, improving prevention, protecting communities, and bolstering efforts to combat illicit synthetic drugs like fentanyl. The policies contained in the legislation were advanced through regular order by the House Energy and Commerce Committee and the Ways and Means Committee. HR 3325 Introduced July 20, 2017 by Joe Barton (R-TX). This bill amends title XIX of the Social Security Act to provide states with the option of providing coordinated care for children with complex medical conditions through a health home, and for other purposes. HR 4143 Introduced October 26, 2017 by Jason Smith (R-MO). The Dialysis Patients Demonstration Act of 2017 establishes a demonstration program to provide integrated care for Medicare beneficiaries with end-stage renal disease, and for other purposes. HR 6478 Introduced July 23, 2018 by John Sarbanes (D-MD). The Biosimilars Competition Act of 2018 enhances competition for prescription drugs by increasing the ability of the Department of Justice and Federal Trade Commission to enforce existing antitrust laws regarding biologic and biosimilar products, and for other purposes. S 2554 Introduced March 14, 2018 by Susan Collins (R-ME). The Patient Right to Know Drug Price Act of 2018. Americans overspend by an estimated $135 million on prescriptions through their insurance, in cases where their drugs would cost less out of pocket. Yet pharmacists are often under gag orders from telling customers about that discrepancy. This bill would end this practice.

Client expense: $250,000 · Firm income: Not reported

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

Issues related to pharmaceutical prices. H.R. 6, SUPPORT for Patients and Communities Act; S.2680, Opioid Crisis Response Act of of 2018 and issues related to controlled substances; monitored S. 2554 / H.R. 6143, the Patient Right to Know Drug Prices Act; monitored H.R. 3325, the Advancing Care for Exceptional Kids Act (ACE Kids) and H.R. 7212, IMPROVE Act. S. 1194, Medical Nutrition Equity Act. H.R. 4724, Medicare IVIG Access Enhancement Act.

Client expense: Not reported · Firm income: $52,500

Government targets: HOUSE OF REPRESENTATIVES, Office of the Vice President of the United States, SENATE