Prescription Drug Price Transparency Act

S. 413, Improving Transparency and Accuracy in Medicare Part D Spending Act (Capito) - PDP/MA-PD payments on clean claims from pharmacies S. 428, ACE Kids Act (Grassley) - coordinated care for children with complex medical conditions S. 1016, CONNECT For Health Act (Schatz) - telehealth S. 1169, Medicaid CARE Act (Durbin-Portman) - changes to Medicaid IMD exclusion S. 1688, Empowering Medicare Seniors to Negotiate Drug Prices Act (Klobuchar) - Part D price negotiations S. 1804, Medicare for All Act (Sanders) - single payer health system S. 1890, Chronic Kidney Disease Improvement in Research and Treatment and Medigap Access (Cardin) - Medigap coverage for beneficiaries with end-stage renal disease S. 1909, BENES Act (Casey) - notifications of Medicare eligibility S. 2027, Medicaid Third Party Liability Act (Portman) - Medicaid third party liability S. 2051, Medicare Care Coordination Improvement Act of 2017 (Portman) - barriers to payment reform models S. 2227, EMPOWER Care Act (Portman-Cantwell) - Medicaid Money Follows the Person Demonstration S. 2707, Informing Seniors About Opioids Act (Nelson) - opioid issues S. 2901, Expanding Telehealth Response to Ensure Addiction Treatment Act (Thune) - opioid issues S. 2904, Medicaid Substance Use Disorder Treatment Via Telehealth Act (Carper) - opioid issues S. 2908, Electronic Prior Authorization in Medicare Part D Act (Roberts) - opioid issues S. 3327, SENIOR Communities Protection Act (Cortez Masto) - preventing fraudulent opioid prescriptions S. 3496, Improving Seniors Access to Quality Benefits Act (Daines-King) - study on MA benchmark cap S. 3497, Medicare Advantage Quality Payment Relief Act (Daines-King) - MA benchmark cap S. 3702, Right Rebate Act (Wyden-Grassley) - Medicaid drug rebate program Draft Bill: Medicare Long-Term Care Services and Supports Act (Pallone) - Long-Term Services and Supports Program H.R. 6, SUPPORT Patients and Families Act (Walden) - opioid initiatives, Medicare and Medicaid issues, budget offsets H.R. 695, Continuing Appropriations Act (Schiff) - Money Follows the Person demonstration, spousal impoverishment protections H.R. 849, Protecting Seniors Access to Medicare Act (Roe) - Independent Payment Advisory Board H.R. 908, Medicare Advantage Quality Payment Relief Act (Kelly) - MA payment cap H.R. 1038, Improving Transparency and Accuracy in Medicare Part D Spending Act (Griffith) - PDP/MA-PD payments on clean claims from pharmacies H.R. 1148, FAST Act (Griffith) - access to telehealth-eligible stroke services under Medicare H.R. 1316, Prescription Drug Price Transparency Act (Collins) - PBM standards for MA and PDP plans H.R. 1995, V-BID for Better Care Act (Black) - value-based insurance design in Medicare Advantage H.R. 2556, CONNECT For Health Act (Black) - telehealth H.R. 2575, BENES Act (Ruiz) - notifications of Medicare eligibility H.R. 2644, Chronic Kidney Disease Improvement in Research and Treatment and Medigap Access (Marino) - Medigap coverage for beneficiaries with end-stage renal disease H.R. 2687, Medicaid CARE Act (Foster-Fitzpatrick) - changes to Medicaid IMD exclusion H.R. 3044, Supplemental Benefits for Chronically Ill Medicare Advantage Enrollees (Meehan) H.R. 3263, Medicare Independence at Home Model of Care (Burgess) - demonstration program H.R. 3325, ACE Kids Act (Barton) - health homes for children with complex medical conditions H.R. 3360, Telehealth Enhancement Act (Harper) - telehealth in Medicare H.R. 3635, Local Coverage Determination Clarification Act (Jenkins) - procedures for Medicare administrative contractors H.R. 3727, Increasing Telehealth Access in Medicare Act (Black) - telehealth in MA plans H.R. 4143, Dialysis PATIENTS Demonstration Act (Smith) - alternative care delivery models and payment methodologies for patients with end-stage renal disease H.R. 4952, Improving Seniors Access to Quality Benefits Act (Kelly) - MA benchmark cap study H.R. 5306, EMPOWER Care Act (Guthrie) - extension of Money Follows the Person demonstration H.R. 5603, Access to Telehealth Services for Substance Use Disorders Act (Matsui) - opioid issues H.R. 5605, Advancing High Quality Treatment for Opioid Use Disorders in Medicare Act (Ruiz) - opioid issues H.R. 5675, drug management programs for at-risk Medicare beneficiaries (Bilirakis) - opioid issues H.R. 5676, SENIOR Communities Protection Act (MacArthur) - preventing fraudulent opioid prescriptions H.R. 5684, Protecting Seniors from Opioid Abuse Act (Kelly) - opioid issues H.R. 5685, Medicare Opioid Safety Education Act (Faso) - opioid issues H.R. 5686, Medicare Clear Health Options in Care for Enrollees Act (Paulsen) - opioid issues H.R. 5715, Strengthening Partnerships to Prevent Opioid Abuse Act (Renacci) - communication between Medicare plan sponsors and CMS H.R. 5773, Preventing Addiction for Susceptible Seniors Act (Roskam) - opioid issues H.R. 5797, IMD CARE Act (Walters) - Medicaid IMD exclusion H.R. 5798, Opioid Screening and Chronic Pain Management Alternatives for Seniors Act (Bucshon) - opioid issues H.R. 5799, Medicaid Drug Review, Utilization, Good Governance Improvement Act (Blackburn) - opioid issues H.R. 5800, Medicaid IMD ADDITIONAL INFO Act (Upton) - opioid issues H.R. 5804, Post-Surgical Injections as an Opioid Alternative Act (Shimkus) - opioid issues H.R. 5808, Medicaid Pharmaceutical Home Act (Bilirakis) - opioid issues H.R. 5809, Postoperative Opioid Prevention Act (Peters) - opioid issues H.R. 5810, Medicaid Health Homes for Opioid-Use-Disorder Medicaid Enrollees Encouraged Act (Lance) - opioid issues H.R. 5812, Improving Medicaid Data Timeliness Act (Griffith) - opioid issues H.R. 6431, Medigap Consumer Protection Act (Levin) - reforms to Medicare supplemental insurance H.R. 6561, Comprehensive Care for Seniors Act (Walorski) -- Program of All-Inclusive Care for the Elderly H.R. 6563, Lower Out-of-Pocket Costs for Seniors Act (Pallone-Neal) - Medicare Part D cliff H.R. 6662, Empowering Seniors Decision Enrollment Act (Paulsen) - special enrollment period for non-deemed Medicare Cost Plan enrollees H.R. 6690, Fighting Fraud to Protect Care for Seniors Act (Roskam) - Medicare pilot program for smart card technology H.R. 7122, Shared Accountability for Improved Patient Outcomes Act (Paulsen) - value-based payment and delivery arrangements H.R. 7217, IMPROVE Act (Barton) - Money Follows the Person demonstration, ACE Kids Act, Medicare drug rebate program, spousal impoverishment protections H.R. 7223, Right Rebate Act (Schrader-Welch) - Medicaid drug rebate program H.R. 7247, Incentivizing Shared Risk in Medicare Advantage Act (Brady) - MA prior authorization H.R. 7249, Better Prior Authorization Notification Act (Reed) - MA prior authorization H.R. 7250, Prior Authorization Improvement Act (Kelly) - MA prior authorization Regulatory Issues: Ongoing implementation issues for the Medicare Advantage (MA) and Medicare Part D prescription drug programs, including risk adjustment methodology, network adequacy and provider directories, encounter data and other data-related issues, and audit issues; bidding and payment issues (including MA rate assumptions, MA coding intensity, MA Secondary Payer issues, Part D reinsurance, Part D low income subsidies, Part D direct and indirect remuneration (DIR), and audits); calendar year 2020 policy and technical regulation for MA and Part D; MA and Part D proposed rule on drug pricing changes for 2020; CMSs price transparency proposal for direct-to-consumer advertisements; issues relating to 2019 Rate Notice and Call Letter; in-home health risk assessments; Medicare Medical Loss Ratio issues; implementation of sequestration under the Medicare Advantage and Part D programs; implications of the health insurer fee for MA and Part D plans; application process, audits to evaluate compliance with MA and Part D program rules, benefit design rules, enrollment rules, requirements for notice and denial forms, marketing materials review and approval, marketing activities, including conduct and compensation of brokers and agents and plan sponsor marketing staff; measurement and oversight of plan performance including Special Needs Plans (SNPs); quality measures, grievance and appeals processes, fraud and abuse compliance including training; contracting issues for Dual Eligible SNPs; Bipartisan Budget Act of 2018 changes to SNPs; Federal preemption of State authority under MA and Part D programs, Part D prescription drug event data reporting, Part D formulary rules, Part D pharmacy access standards, Part D coverage gap discount program, including employer group waiver plan (EGWP) issues, and other operational issues; issues raised by Part D coverage of new specialty drugs, the Part D non-interference policy and related issues (e.g., preferred pharmacy and any willing pharmacy requirements, standards for network pharmacy reimbursement, and policies regarding sponsor negotiation of pharmacy price concessions); CMS's proposed Part B drug demonstration program; Medication Therapy Management Program requirements and the Center for Medicare and Medicaid Innovation (CMMI) Demonstration; MA EGWP issues; CMMI's value-based insurance design (VBID) demonstration; Part D requirements for offering basic and enhanced alternative plans; MA and Part D systems issues affecting enrollment and disenrollment processing and payment and other operational issues; issues relating to MA and Part D Star Rating system including measures, the methodology for calculating ratings, and the role of the ratings for payment purposes; implementation of the Affordable Care Act (ACA) and the Bipartisan Budget Act of 2018 changes to the Part D coverage gap; functionality of the Medicare Personal Plan Finder and Drug Plan Finder; National Medicare Education Program; Medicare demonstration program on performance-based payments for physician groups; physician quality reporting initiative; issues relating to Medicare coverage policy and national coverage decisions; new payment system for physicians under MACRA, including implications for MA and Part D plans; Medicare clinical trials; Medicare/Medicaid integration for dual eligibles, including implementation of the Capitated Financial Alignment Demonstration and related issues (e.g., quality ratings); Medicaid managed care regulations and policies, including CMS's substantial revisions to the managed care regulations, mental health parity rules, the Medicaid managed care actuarial soundness standard, quality oversight, Medicaid and CHIP Payment and Access Commission (MACPAC), grievance and appeals processes, fraud and abuse compliance, beneficiary information requirements, treatment of Medicaid health plan member hospital days in the upper payment limit calculation; policies affecting State Medicaid funding, including block grants, the calculation of the federal medical assistance (federal matching) percentage (FMAP), and intergovernmental transfers (IGTs); coordination of benefits with state Medicaid programs; Medicaid prescription drug cost issues affecting Medicaid health plans including issues raised by Medicaid coverage of new specialty drugs; health plan-related Childrens Health Insurance Program (CHIP) issues, including eligibility and outreach issues and CHIP reauthorization; implementation of Medicaid changes made in Deficit Reduction Act of 2005, including Medicaid managed care organization provider tax issues; standards for electronic prescribing; implementation of Medicaid changes of interest to Medicaid health plans made in the ACA including Medicaid expansion, the managed care organization (MCO) prescription drug rebate provisions, minimum payments to primary care providers (PCPs), interactions between the Medicaid program and health insurance exchanges, and Medicaid and CHIP maintenance of effort (MOE) requirements; implications of the health insurer fee for Medicaid health plans; issues related to Medicaid Managed long-term care including home and community-based waiver services (HCBS); expanding the availability of Medicare Advantage and Medicaid health plan telemedicine programs; implications of the new non-discrimination rules for health plans participating in public programs; issues related to Medigap coverage; issues related to business continuity in relation to pandemics or natural events (e.g., hurricane, tornado, etc.); cybersecurity; provider directories; value-based insurance design models; issues relating to prescription drug price blueprint; Part D prescriber enrollment requirements; Part D recovery audit contractor programs; issues relating to enrollment of beneficiaries with ESRD into MA plans; socioeconomic status impacts on star ratings related to MA and Part D programs; and other issues relating to health care reform implementation.

Client expense: $1,550,000 · 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

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: $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. 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

Stopping the application of the sequester cut (current and new) to Medicare Part B drug reimbursement (no bill). Fixing the 340B drug discount program, including PAUSE Act (H.R. 4710), HELP Act (S. 2312, and Ensuring the Value of the 340B Program Act (S. 2453) and other legislation in progress. Fixing Medicare Part B drug reimbursement by eliminating the manufacturer-to-wholesaler prompt pay discount from the calculation of average sales price, the basis of Part B drug reimbursement (H.R. 1920, S. 1304). Moving Medicare Part B to Part D (no bill). Misc. issues dealing with pharmacy benefit managers and patient and pharmacy abuses (includes bills H.R 1316 - Prescription Drug Price Transparency Act; H.R.1038 - Improving Transparency and Accuracy in Medicare Part D Spending Act; and H.R. 5958 - Phair Pricing Act of 2018}. Oncology Care Model (CMS/CMMI; no bill). Various drug pricing/costs (no bill). STEP therapy (no bill). International Pricing Index Model (no bill)

Client expense: $138,700 · Firm income: Not reported

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

Pharmacy issues, prescription drug supply chain issues, drug shortages, prescription drug abuse and diversion; support for legislation to preserve patient access to oral oncolytics dispensed by community-based cancer clinics (H.R. 1316); DIR (H.R. 1038), advocacy related to ending retroactive direct and indirect renumeration fees levied on pharmacists; Provider status (H.R. 592), advocacy related to recognizing and reimbursing pharmacists for providing appropriate medical services; H.R. 6688, The Analyzing and Leveraging Existing Rx Transactions (ALERT) Act.

Client expense: $210,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, 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. 1316-The Prescription Drug Price Transparency Act (MAC); H.R. 1038 & S.413-Improving Transparency and Accuracy in Medicare Part D Drug Spending Act (DIR); S. 771 and H.R. 1776, Improving Access to Affordable Prescription Drug Act,; HHS/OIG Rule RIN - 936-AA08 entitled, Removal Of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to prescription drug abuse, medication adherence, and drug price transparency. H.R. 1316, The Prescription Drug Price Transparency Act of 2017 H.R. 5343, The Prescription Transparency Act of 2018 H.R. 6, The SUPPORT for Patients and Communities Act of 2018

Client expense: $1,993,000 · Firm income: Not reported

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

Issues related to prescription drug abuse and Medicare Part D. S.413/H.R. 1039, The Improving Transparency and Accuracy in Medicare Part D Spending Act of 2017 H.R.1316, The Prescription Drug Price Transparency Act of 2017 H.R. 5958, The Phair Pricing Act of 2018 H.R. 4143/S. 2065, The Dialysis PATIENTS Demonstration Act of 2017

Client expense: $1,993,000 · Firm income: Not reported

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

Legislation and regulations affecting the long-term care pharmacy industry, S413, HR1316, HR1038

Client expense: Not reported · Firm income: $90,000

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), 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 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)

S. 413, Improving Transparency and Accuracy in Medicare Part D Spending Act (Capito) - PDP/MA-PD payments on clean claims from pharmacies S. 428, ACE Kids Act (Grassley) - coordinated care for children with complex medical conditions S. 1016, CONNECT For Health Act (Schatz) - telehealth S. 1169, Medicaid CARE Act (Durbin-Portman) - changes to Medicaid IMD exclusion S. 1688, Empowering Medicare Seniors to Negotiate Drug Prices Act (Klobuchar) - Part D price negotiations S. 1804, Medicare for All Act (Sanders) - single payer health system S. 1890, Chronic Kidney Disease Improvement in Research and Treatment and Medigap Access (Cardin) - Medigap coverage for beneficiaries with end-stage renal disease S. 1909, BENES Act (Casey) - notifications of Medicare eligibility S. 2027, Medicaid Third Party Liability Act (Portman) - Medicaid third party liability S. 2051, Medicare Care Coordination Improvement Act of 2017 (Portman) - barriers to payment reform models S. 2227, EMPOWER Care Act (Portman-Cantwell) - Medicaid Money Follows the Person Demonstration S. 2707, Informing Seniors About Opioids Act (Nelson) - opioid issues S. 2901, Expanding Telehealth Response to Ensure Addiction Treatment Act (Thune) - opioid issues S. 2904, Medicaid Substance Use Disorder Treatment Via Telehealth Act (Carper) - opioid issues S. 2908, Electronic Prior Authorization in Medicare Part D Act (Roberts) - opioid issues S. 3327, SENIOR Communities Protection Act (Cortez Masto) - preventing fraudulent opioid prescriptions S. 3496, Improving Seniors Access to Quality Benefits Act (Daines-King) - study on MA benchmark cap S. 3497, Medicare Advantage Quality Payment Relief Act (Daines-King) - MA benchmark cap S. 3702, Right Rebate Act (Wyden-Grassley) - Medicaid drug rebate program Draft Bill: Medicare Long-Term Care Services and Supports Act (Pallone) - Long-Term Services and Supports Program H.R. 6, SUPPORT Patients and Families Act (Walden) - opioid initiatives, Medicare and Medicaid issues, budget offsets H.R. 695, Continuing Appropriations Act (Schiff) - Money Follows the Person demonstration, spousal impoverishment protections H.R. 849, Protecting Seniors Access to Medicare Act (Roe) - Independent Payment Advisory Board H.R. 908, Medicare Advantage Quality Payment Relief Act (Kelly) - MA payment cap H.R. 1038, Improving Transparency and Accuracy in Medicare Part D Spending Act (Griffith) - PDP/MA-PD payments on clean claims from pharmacies H.R. 1148, FAST Act (Griffith) - access to telehealth-eligible stroke services under Medicare H.R. 1316, Prescription Drug Price Transparency Act (Collins) - PBM standards for MA and PDP plans H.R. 1995, V-BID for Better Care Act (Black) - value-based insurance design in Medicare Advantage H.R. 2556, CONNECT For Health Act (Black) - telehealth H.R. 2575, BENES Act (Ruiz) - notifications of Medicare eligibility H.R. 2644, Chronic Kidney Disease Improvement in Research and Treatment and Medigap Access (Marino) - Medigap coverage for beneficiaries with end-stage renal disease H.R. 2687, Medicaid CARE Act (Foster-Fitzpatrick) - changes to Medicaid IMD exclusion H.R. 3044, Supplemental Benefits for Chronically Ill Medicare Advantage Enrollees (Meehan) H.R. 3263, Medicare Independence at Home Model of Care (Burgess) - demonstration program H.R. 3325, ACE Kids Act (Barton) - health homes for children with complex medical conditions H.R. 3360, Telehealth Enhancement Act (Harper) - telehealth in Medicare H.R. 3635, Local Coverage Determination Clarification Act (Jenkins) - procedures for Medicare administrative contractors H.R. 3727, Increasing Telehealth Access in Medicare Act (Black) - telehealth in MA plans H.R. 4143, Dialysis PATIENTS Demonstration Act (Smith) - alternative care delivery models and payment methodologies for patients with end-stage renal disease H.R. 4952, Improving Seniors Access to Quality Benefits Act (Kelly) - MA benchmark cap study H.R. 5306, EMPOWER Care Act (Guthrie) - extension of Money Follows the Person demonstration H.R. 5603, Access to Telehealth Services for Substance Use Disorders Act (Matsui) - opioid issues H.R. 5605, Advancing High Quality Treatment for Opioid Use Disorders in Medicare Act (Ruiz) - opioid issues H.R. 5675, drug management programs for at-risk Medicare beneficiaries (Bilirakis) - opioid issues H.R. 5676, SENIOR Communities Protection Act (MacArthur) - preventing fraudulent opioid prescriptions H.R. 5684, Protecting Seniors from Opioid Abuse Act (Kelly) - opioid issues H.R. 5685, Medicare Opioid Safety Education Act (Faso) - opioid issues H.R. 5686, Medicare Clear Health Options in Care for Enrollees Act (Paulsen) - opioid issues H.R. 5715, Strengthening Partnerships to Prevent Opioid Abuse Act (Renacci) - communication between Medicare plan sponsors and CMS H.R. 5773, Preventing Addiction for Susceptible Seniors Act (Roskam) - opioid issues H.R. 5797, IMD CARE Act (Walters) - Medicaid IMD exclusion H.R. 5798, Opioid Screening and Chronic Pain Management Alternatives for Seniors Act (Bucshon) - opioid issues H.R. 5799, Medicaid Drug Review, Utilization, Good Governance Improvement Act (Blackburn) - opioid issues H.R. 5800, Medicaid IMD ADDITIONAL INFO Act (Upton) - opioid issues H.R. 5804, Post-Surgical Injections as an Opioid Alternative Act (Shimkus) - opioid issues H.R. 5808, Medicaid Pharmaceutical Home Act (Bilirakis) - opioid issues H.R. 5809, Postoperative Opioid Prevention Act (Peters) - opioid issues H.R. 5810, Medicaid Health Homes for Opioid-Use-Disorder Medicaid Enrollees Encouraged Act (Lance) - opioid issues H.R. 5812, Improving Medicaid Data Timeliness Act (Griffith) - opioid issues H.R. 6431, Medigap Consumer Protection Act (Levin) - reforms to Medicare supplemental insurance H.R. 6561, Comprehensive Care for Seniors Act (Walorski) -- Program of All-Inclusive Care for the Elderly H.R. 6563, Lower Out-of-Pocket Costs for Seniors Act (Pallone-Neal) - Medicare Part D cliff H.R. 6662, Empowering Seniors Decision Enrollment Act (Paulsen) - special enrollment period for non-deemed Medicare Cost Plan enrollees H.R. 6690, Fighting Fraud to Protect Care for Seniors Act (Roskam) - Medicare pilot program for smart card technology H.R. 7122, Shared Accountability for Improved Patient Outcomes Act (Paulsen) - value-based payment and delivery arrangements H.R. 7217, IMPROVE Act (Barton) - Money Follows the Person demonstration, ACE Kids Act, Medicare drug rebate program, spousal impoverishment protections H.R. 7223, Right Rebate Act (Schrader-Welch) - Medicaid drug rebate program H.R. 7247, Incentivizing Shared Risk in Medicare Advantage Act (Brady) - MA prior authorization H.R. 7249, Better Prior Authorization Notification Act (Reed) - MA prior authorization H.R. 7250, Prior Authorization Improvement Act (Kelly) - MA prior authorization Regulatory Issues: Ongoing implementation issues for the Medicare Advantage (MA) and Medicare Part D prescription drug programs, including risk adjustment methodology, network adequacy and provider directories, encounter data and other data-related issues, and audit issues; bidding and payment issues (including MA rate assumptions, MA coding intensity, MA Secondary Payer issues, Part D reinsurance, Part D low income subsidies, Part D direct and indirect remuneration (DIR), and audits); calendar year 2020 policy and technical regulation for MA and Part D; MA and Part D proposed rule on drug pricing changes for 2020; CMSs price transparency proposal for direct-to-consumer advertisements; issues relating to 2019 Rate Notice and Call Letter; in-home health risk assessments; Medicare Medical Loss Ratio issues; implementation of sequestration under the Medicare Advantage and Part D programs; implications of the health insurer fee for MA and Part D plans; application process, audits to evaluate compliance with MA and Part D program rules, benefit design rules, enrollment rules, requirements for notice and denial forms, marketing materials review and approval, marketing activities, including conduct and compensation of brokers and agents and plan sponsor marketing staff; measurement and oversight of plan performance including Special Needs Plans (SNPs); quality measures, grievance and appeals processes, fraud and abuse compliance including training; contracting issues for Dual Eligible SNPs; Bipartisan Budget Act of 2018 changes to SNPs; Federal preemption of State authority under MA and Part D programs, Part D prescription drug event data reporting, Part D formulary rules, Part D pharmacy access standards, Part D coverage gap discount program, including employer group waiver plan (EGWP) issues, and other operational issues; issues raised by Part D coverage of new specialty drugs, the Part D non-interference policy and related issues (e.g., preferred pharmacy and any willing pharmacy requirements, standards for network pharmacy reimbursement, and policies regarding sponsor negotiation of pharmacy price concessions); CMS's proposed Part B drug demonstration program; Medication Therapy Management Program requirements and the Center for Medicare and Medicaid Innovation (CMMI) Demonstration; MA EGWP issues; CMMI's value-based insurance design (VBID) demonstration; Part D requirements for offering basic and enhanced alternative plans; MA and Part D systems issues affecting enrollment and disenrollment processing and payment and other operational issues; issues relating to MA and Part D Star Rating system including measures, the methodology for calculating ratings, and the role of the ratings for payment purposes; implementation of the Affordable Care Act (ACA) and the Bipartisan Budget Act of 2018 changes to the Part D coverage gap; functionality of the Medicare Personal Plan Finder and Drug Plan Finder; National Medicare Education Program; Medicare demonstration program on performance-based payments for physician groups; physician quality reporting initiative; issues relating to Medicare coverage policy and national coverage decisions; new payment system for physicians under MACRA, including implications for MA and Part D plans; Medicare clinical trials; Medicare/Medicaid integration for dual eligibles, including implementation of the Capitated Financial Alignment Demonstration and related issues (e.g., quality ratings); Medicaid managed care regulations and policies, including CMS's substantial revisions to the managed care regulations, mental health parity rules, the Medicaid managed care actuarial soundness standard, quality oversight, Medicaid and CHIP Payment and Access Commission (MACPAC), grievance and appeals processes, fraud and abuse compliance, beneficiary information requirements, treatment of Medicaid health plan member hospital days in the upper payment limit calculation; policies affecting State Medicaid funding, including block grants, the calculation of the federal medical assistance (federal matching) percentage (FMAP), and intergovernmental transfers (IGTs); coordination of benefits with state Medicaid programs; Medicaid prescription drug cost issues affecting Medicaid health plans including issues raised by Medicaid coverage of new specialty drugs; health plan-related Childrens Health Insurance Program (CHIP) issues, including eligibility and outreach issues and CHIP reauthorization; implementation of Medicaid changes made in Deficit Reduction Act of 2005, including Medicaid managed care organization provider tax issues; standards for electronic prescribing; implementation of Medicaid changes of interest to Medicaid health plans made in the ACA including Medicaid expansion, the managed care organization (MCO) prescription drug rebate provisions, minimum payments to primary care providers (PCPs), interactions between the Medicaid program and health insurance exchanges, and Medicaid and CHIP maintenance of effort (MOE) requirements; implications of the health insurer fee for Medicaid health plans; issues related to Medicaid Managed long-term care including home and community-based waiver services (HCBS); expanding the availability of Medicare Advantage and Medicaid health plan telemedicine programs; implications of the new non-discrimination rules for health plans participating in public programs; issues related to Medigap coverage; issues related to business continuity in relation to pandemics or natural events (e.g., hurricane, tornado, etc.); cybersecurity; provider directories; value-based insurance design models; issues relating to prescription drug price blueprint; Part D prescriber enrollment requirements; Part D recovery audit contractor programs; issues relating to enrollment of beneficiaries with ESRD into MA plans; socioeconomic status impacts on star ratings related to MA and Part D programs; 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

H.R.413/H.R.1038: Improving Transparency and Accuracy in Medicare Part D Spending Act--provisions restricting payer quality payment programs in Medicare Part D. S.771/H.R.1776: Improving Access to Affordable Prescription Drugs Act--issues related to ensuring a competitive marketplace for prescription drugs. H.R.1316: The Prescription Drug Price Transparency Act--issues related to ensuring the continuity of MAC pricing. 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 Proposed Rule & Request for Information --Provisions on Part D. Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs, provisions affecting market competition for prescription drugs and the drug supply chain. CMS Proposed and Final Policy Changes and Updates for Medicare Advantage and the Prescription Drug Benefit Program for Contract Year 2019 (CMS-4182-P), provisions in a Request for Information related to rebates at the point-of-sale and pharmacist direct and indirect renumeration. Proposed HHS-OIG rule currently under OMB review entitled, Removal of Safe Harbor Protections for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection, RIN-936-AAO8. (See https://www.reginfo.gov/public/do/eoReviewSearch for questions). Outreach and education on pharmacy Direction and Indirection Remuneration in Medicare. Provisions related to opening the Medicare doughnut hole in P.L. 115-123.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Legislation to address abuses of the REMS program to allow generic drugs to come to market faster. H.R.2212/S.974: CREATES Act--provisions related to removing barriers to generic competition. H.R.1316: The Prescription Drug Price Transparency Act--issues related to ensuring the continuity of MAC pricing. Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs, provisions affecting market competition for prescription drugs and the drug supply chain.

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

Government targets: HOUSE OF REPRESENTATIVES, 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. 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

H.R. 1038 & S.413-Improving Transparency and Accuracy in Medicare Part D Drug Spending Act (DIR); S.771 & H.R. 1776-Improving Access to Affordable Prescription Drugs Act; H.R.1316-The Prescription Drug Price Transparency Act; HHS-OIG rule RIN -936-AAO8 entitled, Removal of Safe Harbor Protections for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection.

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

Government targets: HOUSE OF REPRESENTATIVES, 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

S. 870 - Chronic Care S. 251 - Protecting Medicare from Executive Action of 2017 H.R. 849/S. 260 - Protecting Seniors' Access to Medicare Act of 2017 H.R. 242/S. 41 - Medicare Prescription Drug Price Negotiation Act of 2017 S. 348 - Prescription Drug and Health Improvement Act of 2017 H.R. 1316 - Prescription Drug Price Transparency Act H.J.Res. 51/S.J.Res. 16 - IPAB discontinuation H.R. 3921 - Healthy Kids Act S. 1827 - Kids Act of 2017 ***, no specific bill(s), Medicare and Medicaid Drug Reimbursement, Medicaid Rebate, dual eligibles, Sunshine, discount cards, MedPAC, biosimilars, Alternative Payment Models, Value based Purchasing, coding, CMMI, Part B, Part D, non-interference, IPAB, donut hole, Part D cliff, 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), 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

Real World Evidence Patient Reported Outcomes Medical Product Communications Act of 2017, HR 1703 Prescription Drug Price Transparency Act, HR 1316 Drug Pricing Biosimilars Patient Right to Know Drug Pricing Act, S.2554 Know the Lowest Price Act of 2018, S. 2553 Know the Cost Act of 2018, H.R. 6733 Medicare Part B coverage policy Health Reimbursement Arrangements

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

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

FAST Genetics Act of 2017 (H.R. 2051) CREATES Act of 2017 (H.R. 2212/S. 974) Preserve Access to Affordable Generics Act (S. 124) 340B PAUSE ACT (H.R. 4710) Legislation to place a moratorium on the 340B drug payment cuts in the CY 2018 Outpatient Prospective Payment System Rule (H.R. 4392) Protecting Jessica Grubbs Legacy Act (S. 1850) Overdose Prevention and Patient Safety Act (H.R. 3545, 5795, 6082) ACA Medicaid disproportionate share hospital (DSH) cuts Childrens Health Insurance Program (CHIP) funding ACO Improvement Act of 2017 (H.R. 4580) Medicare Home Infusion Therapy Access Act of 2017 (S. 1738)/ Section 101 of Medicare Part B Improvement Act of 2017 (H.R. 3178) Prescription Drug Price Transparency Act (MAC bill) (H.R.1316) Improving Transparency and Accuracy in Medicare Part D Spending Act (H.R.1038/S.413) Ensuring Seniors Access to Local Pharmacies Act of 2017 (H.R.1939/S.1044) Pharmacy and Medically Underserved Areas Enhancement Act (H.R.592/S.109) CARA 2.0 Act of 2018 (H.R.5311/S.2456) Biosimilars Competition Act of 2018 (H.R. 6478) Know the Lowest Price Act of 2018 (S.2553) Patient Right to Know Drug Prices Act (S.2554) SUPPORT for Patients and Communities Act (H.R. 6)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1245/S. 469 The Affordable and Safe Prescription Drug Importation Act H.R. 1316 - Prescription Drug Price Transparency Act H.R. 749 Lower Drug Costs Through Competition H.R.2430/S. 934 - FDA Reauthorization Act of 2017 H.R. 4841 - Standardizing Electronic Prior Authorization for Safe Prescribing Act H.R. 6733 - Know the Cost Act H.R. 6143/ S. 2554 - Patient Right to Know Drug Prices Act H.R. 6144/ S. 2553 - Know the Lowest Price Act H.R. 6641 - True Cost-sharing of Seniors Drugs Transparency (True COST) Act H.R. 5958 - Phair Pricing Act

Client expense: $640,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, 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

HR 1316 To amend title XVIII of the Social Security Act to provide for pharmacy benefits manager standards under the Medicare prescription drug program and Medicare Advantage program to further transparency of payment methodologies to pharmacies, and for other purposes. HR 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. HR 592, S 109 To amend title XVIII of the Social Security Act to provide for coverage under the Medicare program of pharmacist services. HR 3528/S 2460 Every Prescription Conveyed Securely Act -- To amend title XVIII of the Social Security Act to require e-prescribing for coverage under part D of the Medicare program of prescription drugs that are controlled substances. HR 7083 This Act may be cited as the Access to Genetic Counselor Services Act of 2018. To amend title XVIII of the Social Security Act to provide for expanded coverage of services furnished by genetic counselors under part B of the Medicare program, and for other purposes.

Client expense: $34,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 1316 To amend title XVIII of the Social Security Act to provide for pharmacy benefits manager standards under the Medicare prescription drug program and Medicare Advantage program to further transparency of payment methodologies to pharmacies, and for other purposes. HR 1245/S 469 To amend the Federal Food, Drug, and Cosmetic Act to allow for the importation of affordable and safe drugs by wholesale distributors, pharmacies, and individuals. S 2553 Know the Lowest Price Act of 2018 -- prohibits health plans and pharmacy benefit managers from restricting pharmacies from informing individuals regarding the prices for certain drugs and biologicals S 2554 Patient Right to Know Drug Prices Act -- ensure that health insurance issuers and group health plans do not prohibit pharmacy providers from providing certain information to enrollees S 2645 To establish a demonstration program under which the Drug Enforcement Administration provides grants to certain States to enable those States to increase participation in drug take-back programs. HR 6733 This Act may be cited as the Know the Cost Act of 2018. To amend title XXVII of the Public Health Service Act and title XVIII of the Social Security Act to prohibit group health plans, health insurance issuers, prescription drug plan sponsors, and Medicare Advantage organizations from limiting certain information on drug prices.

Client expense: $34,000 · Firm income: Not reported

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)

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)

Pharmacy issues, prescription drug supply chain issues, drug shortages, prescription drug abuse and diversion; support for legislation to preserve patient access to oral oncolytics dispensed by community-based cancer clinics (H.R. 1316); DIR (H.R. 1038), advocacy related to ending retroactive direct and indirect renumeration fees levied on pharmacists; Provider status (H.R. 592), advocacy related to recognizing and reimbursing pharmacists for providing appropriate medical services; H.R. 6688, The Analyzing and Leveraging Existing Rx Transactions (ALERT) Act.

Client expense: $210,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, 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 H.R. 3635: Local Coverage Deteremination Clarification Act of 2018 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 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. __: To amend title XIX of the Social Security Act to provide the Medicare Payment Advisory Commission with access to certain drug rebate information 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 S. 3000: Patient Advocacy Transparency Act - Social Security Act amendments 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 Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Prescription drug abuse 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) 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) Medicare Part D Doughnut Hole Medicare Part D Cliff S 974/HR 2212 - CREATES Act340B Drug Pricing Program Medicare Part D Six Protected Classes

Client expense: $1,130,000 · Firm income: Not reported

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

Issues related to prescription drug abuse, medication adherence, drug price transparency, and gag clauses. H.R. 1316, The Prescription Drug Price Transparency Act of 2017 S. 2553/H.R. 6144, The Know the Lowest Price Act of 2018 S. 2554/H.R. 6143, The Patient Right to Know Drug Prices Act of 2018 H.R. 5343, The Prescription Transparency Act of 2018 H.R. 6, The SUPPORT for Patients and Communities Act of 2018 S. 2680, The Opioids Crisis Response Act

Client expense: $1,442,000 · Firm income: Not reported

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

Issues related to prescription drug abuse and Medicare Part D. S.413/H.R. 1039, The Improving Transparency and Accuracy in Medicare Part D Spending Act of 2017 H.R.1316, The Prescription Drug Price Transparency Act of 2017 S. 2553/H.R. 6144, The Know the Lowest Price Act of 2018 H.R. 5958, The Phair Pricing Act of 2018 H.R. 4143/S. 2065, The Dialysis PATIENTS Demonstration Act of 2017

Client expense: $1,442,000 · Firm income: Not reported

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

Legislation and regulations affecting the long-term care pharmacy industry, S413, HR1316, HR1038

Client expense: Not reported · Firm income: $90,000

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), 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 H.R. 3192: CHIP Mental Health Parity Act H.R. 3635: Local Coverage Determination Clarification Act of 2018 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 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. __: To amend title XIX of the Social Security Act to provide the Medicare Payment Advisory Commission with access to certain drug rebate information 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 S. 3000: Patient Advocacy Transparency Act - Social Security Act amendments 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 Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Prescription drug abuse 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) 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: $5,990,000 · 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